Engineering Jobs in Laguna Beach

41 positions found

Field Maintenance Install Technician (Experienced Ironworker)
Salary not disclosed
Anaheim, California 2 days ago
Description:

American Equipment Holdings is an organization of leading overhead crane and hoist fabricators, distributors and field service providers, including American Equipment, Allied Crane, Eastern Crane & Hoist, Facilities Engineering, Kistler Crane & Hoist, Pacific Crane & Hoist, Patriot Crane & Hoist, Shannahan Crane & Hoist, and Washington Crane & Hoist. The consolidated entity is one of the largest independently owned overhead crane and hoist solutions providers in the country, serving over 4,000 customers nationwide.


Together, American Equipment Holdings companies provide comprehensive solutions for everything related to customers’ overhead crane and hoist needs, including OSHA mandated inspections, preventative maintenance and repair field services, parts, engineering, ISO certified fabrication, new and replacement equipment, automated systems, system modernizations and training.


We are looking for a Field Maintenance Install Technician (Experienced Ironworker) in our Anaheim location.


Essential Duties and Responsibilities:

  • Work as part of team to install equipment. With a focus on safety and customer service.
  • Accurately and neatly document work performed using a combination of electronic forms, software applications, and traditional handwritten reports where required.
  • Maintain a clean and safe work environment.
  • Travel may be required to install sites.

Required Skills/Abilities

  • Iron work/steel erection experience.
  • Aptitude for either electrical or mechanical environments as well as familiarity with mechanical and electrical equipment
  • Comfort with working at heights
  • Welding experience- Wire Feed (MIG), Stick (SMAW)
  • Hands-on electro-mechanical maintenance or equivalent military experience a plus
  • Competence in equipment operation. Reach forklifts, scissor lifts.
  • Ability to read blueprints and schematics
  • Ability to work well in a team environment.
  • Strong communication skills
  • Proven commitment to safety
  • Passion for doing things right the first time.
  • Industry certifications including equipment operator, Welding, Rigging will be a plus.
  • Willingness to work overtime is required
  • Possession of a valid driver’s license with good driving record
  • Must pass drug-screen and background check

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.


American Equipment Holdings represents the industry’s leading manufacturers such as Detroit Hoist, Columbus McKinnon, ACCO, R&M, Demag, Gorbel, Spanco, IMS, Harrington, Conductix, Magnetek & PE, among others and customers rely on its design, engineering, fabrication and installation capabilities to meet their unique application needs. American Equipment Holdings serves local, regional and national customers across a variety of end markets, including light & heavy industrial, automotive, mining, public utilities, military, aerospace & defense and energy, among others. For more information, visit of right to lawfully work in the United States required.


We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.



Requirements:




Compensation details: 24-32 Hourly Wage



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Not Specified
Construction Manager
Salary not disclosed
Newport Beach, CA 2 days ago

BCT Development is a fast-growing ground-up multifamily development company based in Newport Beach, CA. We’re looking for a Construction Manager to join our team and help oversee the construction of our active and upcoming build-to-rent communities.


About the role:

This position serves as an Owner’s Representative, working closely with third-party general contractors to keep projects on track in terms of quality, budget, and schedule. It’s a hands-on role that includes site visits, problem-solving, and close coordination with our internal development team. Experience with townhome or horizontal multifamily projects is a plus.


We’re seeking someone who enjoys being in the field, can manage multiple projects, and communicates effectively with contractors, consultants, and stakeholders.


What you’ll do:

  • Represent BCT on active job sites, ensuring projects meet quality, safety, budget, and schedule goals.
  • Oversee general contractors with regular site walks and progress reviews.
  • Assist with reviewing construction documents, schedules, pay applications, and change orders.
  • Participate in value engineering discussions to help keep projects cost-effective and efficient.
  • Collaborate with internal development and operations teams to maintain project scope and timelines.
  • Support the draw process, third-party inspections, and lender/investor reporting.
  • Help identify potential project risks and assist in resolving issues as they arise.
  • Foster strong relationships with GCs, consultants, trade partners, and city officials.


What we’re looking for:

  • Bachelor’s degree in Construction Management, Engineering, Architecture, or a related field (or equivalent experience).
  • 3–7 years of experience in ground-up residential construction management (townhome or multifamily experience a plus).
  • Familiarity with construction budgeting, scheduling, and value engineering.
  • Comfortable managing multiple projects at different stages.
  • Proficiency with Procore, MS Project (or equivalent), Bluebeam, and Excel.
  • Strong communication and problem-solving skills.


Bonus points for:

  • Experience in a development or owner’s rep role.
  • Knowledge of the Southern California market.
  • A proactive, team-oriented mindset and strong field presence.
Not Specified
Electrical Engineer
Salary not disclosed
Irvine, California 6 days ago

Are you an experienced Electrical Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Electrical Engineer to work at their company in Irvine, CA.

Primary Responsibilities/Accountabilities:

  • Identifying gaps in the acquired company's compliance with Work Instructions and SOPs and defining a strategy to close these gaps.
  • Providing input to project goals and progress, and recommending appropriate revisions.
  • Communicating progress, risks, and trade-offs of technical deliverables to project leadership and recommending revisions as needed.
  • Completing complex or Client assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the portfolio.
  • Successfully completed engineering work in electrical design remediation, product design refinement, preparation of specifications, test method validation, and report preparation.
  • Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
  • Completing clear and concise engineering documentation.

Qualifications:

  • Electrical Engineer degree - firm, with 4+ years of experience
  • Must have medical device experience
  • Implantable medical device experience and testing
  • Strong electrical and/or systems engineering design documentation experience, problem-solving skills and attention to detail
  • Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
  • Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
  • Personal drive, individual accountability & a strong bias for action.
  • Up to 10% travel -mostly local.

Preferred:

  • Familiarity with IEC 14708 and 45502 Active Implantable standards
  • Familiarity with IEC 60601 Electrical Medical Equipment standards
  • Experience in Altium and/or LT Spice
  • Experience in medical device design, acceptance, and Design Verification testing
  • Ability to build strong relationships across the organisation and with external stakeholders
Not Specified
Vice President of Technology
Salary not disclosed
Lake Forest, CA 1 week ago

ABOUT ETHIKA:

Ethika is a leading lifestyle brand based in Lake Forest, CA. Since the inception of the brand, Ethika and its team have been determined to live life, innovate, and deliver quality products, while staying true to our biggest asset – our FAMILIE. The Ethika employees, friends, athletes, artists and customers are the core of the brand and the reason we exist.


POSITION SUMMARY:

The Vice President of Technology is responsible for overseeing Ethika’s day-to-day technology operations, digital platforms, infrastructure, and development initiatives. This role focuses on execution, system reliability, scalability, and continuous improvement of the company’s ecommerce and internal technology ecosystem.

The VP of Technology will lead the engineering and development teams, ensure stability across web and cloud environments, manage third-party integrations, and drive efficiency across digital systems that support revenue growth and operational performance. This individual reports directly to the CEO and works cross-functionally with Ecommerce, Operations, Finance, and Marketing teams.


RESPONSIBILITIES:

  • Oversee daily technology operations, ensuring uptime, performance, and system stability
  • Manage and mentor the internal development and infrastructure teams
  • Drive execution of website enhancements, feature rollouts, and system upgrades
  • Maintain and optimize ecommerce platform performance, speed, and scalability
  • Oversee server, cloud, and hosting environments to ensure security and reliability
  • Manage third-party integrations, APIs, and data flows between systems
  • Partner with ecommerce and operations teams to implement technical solutions that improve efficiency and customer experience
  • Establish development timelines, prioritize projects, and ensure on-time delivery
  • Monitor site analytics, performance metrics, and system logs to proactively resolve issues
  • Ensure compliance with data privacy, accessibility, and cybersecurity standards
  • Assist in evaluating and implementing new technologies to support company growth
  • Manage technology-related vendor relationships and contracts


QUALIFICATIONS:

We utilize the following in our tech stack. The ideal candidate will have strong hands-on experience in:

  • PHP
  • MongoDB
  • Vue & Vite
  • Git/GitHub
  • AWS / Cloud Infrastructure
  • API integrations and system architecture


EXPERIENCE:

• Front-end development: 8+ years (Required)

• Back-end development: 8+ years (Required)

• Experience leading engineering or development teams: 5+ years (Required)

• Experience supporting ecommerce platforms and high-traffic websites (Required)


COMPENSATION:

Salary Range: $150,000-$170,000

Not Specified
Water Resources Engineer
Salary not disclosed
Irvine, California 1 week ago

The Water Resources Engineer position will be dedicated to supporting the departments' hydrology and stormwater quality review, analysis, modeling, and report writing. This position also has the opportunity to provide general engineering support for the department on project needs including plan production, design engineering, and other general engineering tasks. Our client understands the importance of work/life balance, which is why they offer a variety of flexible and hybrid work schedules to suit the needs of their dedicated team members.

Duties/Responsibilities:

  • Lead and support activities to ensure compliance with applicable state and federal environmental rules and laws related to stormwater quality.
  • Perform hydrology mapping and calculations using hand calculations and hydrology software.
  • Perform hydraulic calculations to size stormwater devices.
  • Write clear, thorough reports to explain and compile the hydrology and hydraulics (H&H) of the site.
  • Prepare and perform necessary calculations for stormwater reports (i.e. WQMP, LID, SWPPP) and compile reports for submittals.

Requirements:

  • Bachelor's Degree in Civil Engineering, Environmental Engineering, or a related discipline.
  • 3+ years of experience focused on stormwater quality, site hydrology and hydraulics.
  • Proficiency in Civil 3D and H&H software.
Not Specified
Sr. Air Quality Engineer/Scientist (Environmental Compliance Specialist)
Salary not disclosed

Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 2,000 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California's organizations, Yorke successfully solves our clients' Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene.

We are looking for a sharp Sr. Air Quality Engineer/Scientist (Environmental Permitting and Compliance Specialist) to join our team in Southern CA. This is a full-time position from any of our Southern CA offices (Diamond Bar, Long Beach, Los Angeles, San Juan Capistrano, San Diego, Ventura, or Riverside) during our normal business hours. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match.

Position Summary:

The Sr. Air Quality Engineer/Scientist (Environmental Permitting and Compliance Specialist) performs professional engineering work, leading and executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned.

This is a Senior to Principal level position. Positions at this level are assigned to perform the more complex and sensitive duties in the occupational field. The employee in this position may be assigned to train and mentor other employees and/or monitor work produced by other employees.

The candidate qualifications we are seeking include:

  • 10-20+ years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment);
  • Experience in the environmental services industry focusing on leading Air Quality services:
  • Process and equipment review;
  • Air quality permitting under SCAQMD and other Air Districts, including Title V Permitting;
  • RECLAIM implementation and reporting;
  • Annual Emissions Reporting;
  • Air Dispersion Modeling;
  • Air Quality Assessments including Data Analysis and Emission Inventories;
  • General Air Quality Compliance for facilities in CA.
  • Ability to manage and lead active team members on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables;
  • Ability to manage successful relationships with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality;
  • Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, EPA, CARB and/or other similar regulatory agencies;
  • Experience working on-site at client facilities;
  • Prepare reports and submissions in timely manner;
  • Experience with handling highly technical data and technical data interpretation;
  • Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience;
  • CA Regulatory/Compliance experience is required.

Job Requirements:

  • B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (minimum GPA of 3.0);
  • Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently;
  • Desire to train and share technical expertise in environmental rules and regulations with clients and team members;
  • Excellent oral and written communications skills;
  • Experience in conflict resolution and crisis management;
  • Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions;
  • Ability to think critically and develop solutions;
  • Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required);
  • Microsoft 365 Applications, including Sharepoint (a plus)
  • P.E. Certification (a plus).
Not Specified
Senior Counsel, Litigation & IP Strategy
Salary not disclosed
Newport Beach, CA 1 week ago

Senior Counsel, Litigation & IP Strategy


You will lead litigation portfolio with a heavy focus on semiconductor technologies. You will bridge the gap between complex engineering concepts and compelling legal arguments, managing high-stakes disputes across the U.S., EU, and Asia-Pacific.


Key Responsibilities


  • Strategic Oversight: Drive litigation strategy ,semiconductor-related IP, antitrust, trade secrets, and class action matters.


  • Hands-on Execution: Draft pleadings and briefs for high-stakes cases and direct all phases of litigation from discovery through trial and appeal.


  • Technical Translation: Collaborate with engineering teams to translate deep-tech architecture into winning legal positions.


  • Global Risk Management: Manage outside counsel and litigation budgets while navigating regulatory inquiries and ITC Section 337 investigations.


  • Executive Advisory: Partner with senior leadership to align legal risks with broader business and market dynamics.


Who You Are


  • A Proven Expert: J.D. with 8+ years of litigation experience, including 3–5 years in a leadership capacity (In-House/NPE).


  • Semi-Tech Savvy: Deep technical understanding of semiconductor design and memory systems.


  • IP Veteran: Significant experience in patent litigation and inter partes review (IPR) proceedings before the PTAB.


  • Strategic Thinker: You don't just manage cases; you proactively identify and mitigate risk before it hits the docket.


Preferred Qualifications


  • In-house experience at a semiconductor/tech company or NPE


  • Familiarity with SEPs (Standards-Essential Patents) and licensing negotiations.


  • Advanced degree in Electrical Engineering is a major plus.
Not Specified
Mechanical Engineer – Aerospace Thermal Management Systems (Integration & Packaging)
Salary not disclosed
Irvine, California 1 week ago

Mechanical Engineer – Aerospace Thermal Management Systems (Integration & Packaging)

Location: Onsite – Irvine CA

Industry: Aerospace & Defense

Citizenship Requirement: U.S. Citizen

Role Overview

We are seeking two highly skilled Mechanical Engineers with experience in the Aerospace & Defense sector to support the development and integration of advanced thermal management subsystems used across military and commercial platforms globally.

This role focuses on mechanical subsystem development from a packaging and integration perspective, including enclosure design and integration of electronic and fluid control components such as pumps, compressors, fans, and valves. The ideal candidate has hands-on experience developing aerospace-grade subsystems within defined volume and interface constraints, ensuring high reliability, environmental robustness, and compliance with industry standards.

These roles will support programs progressing from Preliminary Design Review (PDR) toward Critical Design Review (CDR) and will involve reuse and adaptation of existing product architectures.

Key Responsibilities

  • Design and develop mechanical enclosures for aerospace electronic and control subsystems such as thermal management systems and related subsystems
  • Package and integrate COTS and custom components into customer-defined volume constraints by integrating components including pumps, compressors, fans, valves, and control electronics
  • Develop detailed CAD models, assemblies, and manufacturing drawings (SolidWorks preferred)
  • Conduct tolerance analysis, GD&T, stack-up analysis, and design for manufacturability (DFM)
  • Support prototype builds, integration activities, testing, and validation
  • Implement design considerations to satisfy and qualify the environmental requirements (shock, vibration, temperature, humidity, EMI/EMC interface considerations) per MIL standards.
  • Collaborate with electrical, controls, thermal, structural, and systems engineering teams
  • Participate in root cause analysis and design refinement
  • Ensure compliance with aerospace and defense standards and documentation practices

Required Qualifications

  • Bachelor's degree in mechanical engineering or equivalent.
  • 5+ years of experience in Aerospace & Defense mechanical subsystem development
  • U.S. Citizen (No Dual Citizenship)
  • Strong mechanical packaging and integration experience
  • Experience designing enclosures housing electronics and fluid/mechanical components
  • Exposure to thermal management systems (ECS, vapor cycle, or liquid cooling preferred but not mandatory)
  • Working knowledge of rotating machinery components (fans, compressors, pumps)
  • Proficiency in CAD tools (SolidWorks preferred; strong experience in other platforms acceptable)
  • Experience with GD&T and tolerance analysis
  • Familiarity with aerospace environmental standards (MIL-STD preferred)
  • Experience supporting qualification and validation testing
  • Strong understanding of materials selection for aerospace applications
  • Ability to work in cross-functional engineering teams

Preferred Qualifications

  • Experience packaging turbomachinery components within constrained aerospace envelopes
  • Exposure to controls systems integration
  • Knowledge of vibration isolation and shock mitigation techniques
  • Experience supporting PDR/CDR processes
  • Familiarity with configuration management and aerospace documentation rigor
  • Exposure to FMEA, reliability analysis, and lifecycle support
Not Specified
Product Development Manager
Salary not disclosed
Irvine, California 1 week ago

Company Description

Project Chemistry is a leading cosmetic formulation and biotechnology innovation lab based in Irvine, California. We partner with emerging and established beauty brands to create breakthrough skin and hair care products that combine scientific rigor, ingredient innovation, and commercial feasibility.

Our expertise spans ingredient discovery, biotech-driven IP creation, advanced active system development, formulation, and technology transfer to contract manufacturers. We work across prestige, mass, and niche categories with a strong emphasis on efficacy, safety, differentiation, and scalability.

At Project Chemistry, we pride ourselves on blending cutting-edge science with commercial practicality to deliver high-performing formulas that stand out in today's competitive beauty market. Our team thrives on collaboration, curiosity, disciplined execution, and pushing the boundaries of innovation in cosmetics. Join us in driving forward innovation and connecting creativity with high-performance solutions.

Role Description

The Product Development Manager is responsible for leading cosmetic skin and hair care projects from concept ideation through formulation approval and technology transfer to contract manufacturers. This role combines strategic product development with disciplined project management to ensure timelines, deliverables, costs, and communication remain aligned throughout the project lifecycle.

The Product Development Manager is responsible for identifying product claims and constructing claims frameworks aligned with ingredient strategy and brand positioning. This role collaborates with internal teams and third-party laboratories to design and oversee claims substantiation testing, ensuring all performance claims are scientifically defensible and commercially impactful.

The Product Development Manager determines specific active ingredient strategies tailored to each client's needs and target claims, translating client briefs into structured product architectures with defined hero actives, supporting ingredient systems, and commercial guardrails. This role evaluates ingredient performance, regulatory alignment, scalability, and cost implications to ensure each concept is scientifically sound and commercially viable.

Responsibilities

  • Lead development of consumer-relevant product concepts from ideation through approval, including defining active ingredient strategies aligned with efficacy goals, claims positioning, regulatory geography, and budget constraints.
  • Identify product claims and work with internal and third-party laboratories to design, coordinate, and oversee claims substantiation testing (e.g., clinical, instrumental, SPF, antioxidant, penetration, TEWL), ensuring all claims are realistic, regulatory-aligned, and supported by credible data.
  • Evaluate supplier materials and construct synergistic active systems that differentiate Project Chemistry's offerings while remaining scalable and manufacturable.
  • Develop preliminary cost of goods estimates during early concept phases and continuously assess the impact of formulation changes on profitability and pricing strategy.
  • Ensure ingredient selections, concentration levels, and delivery systems align with client margin targets and channel positioning.
  • Evaluate and recommend packaging formats based on formula compatibility, brand aesthetic, sustainability goals, minimum order quantities, and lead times.
  • Collaborate with packaging suppliers and contract manufacturers to ensure formulation and packaging decisions are operationally aligned and scale-ready.
  • Own project timelines, milestones, approvals, and deliverables from Statement of Work execution through technology transfer readiness.
  • Manage sampling cycles, revisions, and cross-functional coordination while proactively identifying risks related to scope, cost, or timing.
  • Translate technical challenges into clear client-facing communication and support competitive benchmarking and claims alignment.

Qualifications

  • Bachelor's degree in Cosmetic Science, Chemistry, Chemical Engineering, or a related technical field preferred.
  • 5+ years of experience in cosmetic product development for skin and/or hair care, including active ingredient selection and development strategy guidance.
  • Strong understanding of the beauty product development lifecycle, active ingredient landscape, and supplier ecosystem.
  • Demonstrated ability to build COGS models and evaluate how formulation decisions impact margin targets and pricing tiers.
  • Experience assessing packaging compatibility, minimum order quantities, and contract manufacturing workflows.
  • Clear written and verbal communication skills with ability to manage multiple complex projects simultaneously in a fast-paced environment.
  • Familiarity with claims substantiation testing, tech transfer, and scale-up processes.
Not Specified
Senior Software Engineer (Android)
Salary not disclosed
Irvine, California 1 week ago

*Note that this job is on-site only in Irvine, CA*

Job Summary:

Willow is a health and wellness innovator harnessing the power of artificial intelligence and clinical evidence to drive meaningful change in healthcare. We are using cutting-edge technology, data, and a highly engaging user experience to revolutionize chronic disease management and prevention. We are looking for an experienced Senior Software Engineer to join our growing team. We are looking for strong talent to help us create novel life-changing digital health solutions for our users. We hire creative people and give them autonomy to do great work. Our senior software engineers are comfortable dealing with high-level specifications, working independently and in small teams, and are involved in the product process from start to finish. We need engineers who are excited to try new approaches and collectively learn the right approach to delivering the best health care experiences.

Duties & Responsibilities:

· Work with product managers, designers, and a talented group of engineers to craft unique and beautiful user experiences that will make our mobile solutions best in class.

· Play a critical role in the software architecture, design, and development of our mobile apps.

· Write clean and well-tested code that allows us to keep our applications stable and easily modifiable. Contribute to a knowledge-sharing and an open and collaborative work environment.

Qualifications and Experience

· BS or higher in Computer Science, other related degree, or equivalent work experience.

· 8+ years of experience developing software, with at least 5 years working with Java/Kotlin in mobile application development

· Knowledge of mobile design principles, patterns, and best practices

· Knowledge of push notifications, web technologies and services (HTTP, REST, websocket, etc.)

· Design and development experience with Object Oriented Programming, SOLID principles, MVC, MVVM, Dependency Injection, persisting data

· Understanding of source code management tools, such as Git

· Experience with Kotlin Multiplatform, MongoDB/Realm, Bluetooth framework, IoT and Linux is a plus

· Experience with engineering medical software is a plus

· Team player

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore, the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Not Specified
PCB Design Engineer
🏢 Cyient
Salary not disclosed
Irvine, California 1 week ago

Job Description:

The ideal candidate will have strong experience in multi-layer PCB design for defense electronics systems and proficiency in industry-standard PCB design tools.

Key Responsibilities:

Design and develop multi-layer PCB layouts for defense electronic systems.

Utilize OrCAD/Allegro tools for schematic capture and PCB layout.

Perform high-speed and high-density PCB layout design while ensuring signal integrity and manufacturability.

Ensure PCB designs comply with IPC Class 3 standards and industry best practices.

Collaborate with cross-functional teams including hardware, manufacturing, and testing teams.

Required Skills:

6–10 years of experience in PCB design and layout engineering.

Strong proficiency in OrCAD and Allegro PCB design tools.

Experience with high-speed and high-density PCB layout design.

Knowledge of IPC Class 3 design standards.

IPC CID or CID+ certification is preferred.

Not Specified
Maintenance Coordinator
🏢 Belcan
Salary not disclosed
Irvine, California 1 week ago

Job Title: Maintenance Coordinator (Planning & Scheduling)

Location: Irvine, CA USA 92606

Duration: 06 Months contract (Potential temp to perm)

Payrate: $20/hr.- $28/hr. (depending on experience)

Shift: 1st shift, 6am, 7am or 8am start

Under general supervision, the Maintenance Coordinator is responsible for planning, coordinating, and tracking the timely execution of maintenance activities to support equipment reliability and production requirements. This role ensures accurate system updates, effective use of maintenance resources, and clear communication across Operations, Engineering, EHS, and Procurement to meet internal customer schedules.

Responsibilities may include some or all of the following:

Maintenance Planning and Scheduling:

  • Update the computerized maintenance management system (CMMS) with timely and accurate work order, asset, and parts information.
  • Stage, prioritize, and schedule preventive, predictive, and corrective maintenance to meet production windows and maximize resource utilization.
  • Develop weekly and daily maintenance schedules; coordinate short-range capacity plans and planned shutdowns/turnarounds.
  • Monitor and resolve short-term capacity conflicts (e.g., staffing reassignments, overtime, contractor support, alternate equipment utilization).
  • Manage and schedule contractors/vendors for work performed on site.

Work Order Management

  • Coordinate with support groups (Operations, Engineering, Quality, EHS) to initiate corrective action on work orders placed on hold.
  • Assign Safety Concerns and track to closure.
  • Create, split, and update work orders in the CMMS (e.g., create child/sub-tasks), and coordinate inspections and sign-offs as required.
  • Audit and reconcile documentation to maintain work-in-process (WIP) and asset history accuracy; ensure timely closeout with proper failure codes, labor, and parts usage.
  • Track progress of jobs across maintenance shops, external repair vendors, and calibration labs; escalate discrepancies and delays.

Materials, Tooling, and MRO Inventory:

  • Coordinate release and kitting of materials/components, spares, and consumables to support scheduled work.
  • Identify and communicate component shortages to support maintenance schedules; track purchase order and repair order status.
  • Request and prioritize specialized tooling, calibrated instruments, and permits required at the job site.
  • Monitor packaging, handling, and storage of parts and repaired components to prevent damage and preserve warranty.

Cross-Functional Coordination and Communication:

  • Serve as liaison between Maintenance, EHS, and Operations to resolve scheduling conflicts and align maintenance windows with production demand.

Contractor Management:

  • Ensure all contractors and vendors have been reviewed to comply with company Contractor Management requirements and ensure all EHS rules are adhered to.
  • Participate in tier/team meetings to drive progress on schedule attainment, cost, quality, and reliability goals.
  • Prepare and deliver status updates and reports to team leaders and stakeholders (e.g., job progress, backlog, PM compliance, MTTR/MTBF trends).
  • Reliability, Compliance, and Documentation
  • Support implementation of recovery plans to restore equipment uptime after unplanned events.
  • Maintain current job plans, SOPs, prints/drawings, and technical documentation for maintenance tasks.
  • Adhere to and promote EHS and regulatory requirements (e.g., LOTO, confined space, hot work permits, PPE); support audits and corrective actions.
  • Support continuous improvement and root cause analysis (e.g., 5-Why, fishbone) and implement preventive actions.

Logistics and General Support

  • Move materials and tooling using, dolly, hand truck, or carts as required.
  • Coordinate external contractors/OEMs for specialized maintenance and field service.
  • Train and assist less experienced employees in CMMS use, job planning, and standard work.
  • Perform other related responsibilities as assigned.

Job Requirements:

  • Two years of maintenance planning/scheduling, maintenance coordination, or production support experience in a computerized environment, or demonstrated ability to perform the described responsibilities.
  • Working knowledge of CMMS/EAM systems (e.g., SAP PM, Maximo, EAM, or equivalent) and maintenance workflows (PM/PdM/CM).
  • Understanding of maintenance resource and capacity planning; familiarity with MRO spares and basic MRP concepts.
  • Ability to read and interpret maintenance documentation (routings, job plans, schematics, P&IDs, and blueprints).
  • Proficiency with standard office and reporting tools (e.g. Excel, Outlook); experience with dashboards/reporting preferred.
  • May be required to lift up to 50 lbs. and perform tasks involving standing/walking.
  • Effective verbal, written, and interpersonal communication skills.
  • Demonstrated ability to work collaboratively and be a participative team player.
  • Preferred: exposure to reliability/maintenance frameworks (e.g., TPM, RCM), basic KPIs (PM compliance, backlog, MTBF/MTTR), and contractor/vendor coordination.
Not Specified
Operations Manager - Process Automation
🏢 RIS Rx
Salary not disclosed
Orange, California 1 week ago

Job Title: Operations Manager - Process Automation

Reports to: VP, Operational Excellence

Location: Irvine, CA

About Our Organization

RIS Rx (pronounced "RISE") is a healthcare technology startup in the pharmaceutical patient access and affordability space. We have quickly become an industry leader with a valuable service portfolio that addresses common patient access barriers, leading to better treatment outcomes and improved quality of life. Here at RIS Rx, we invite our teammates and partners to "Rise Up" with us to bring accessible healthcare to everyone.

Job Summary

We are growing exponentially so we need to build products that scale. This Operations Manager will pave the way for our PMs and Engineers by partnering with operators to measure performance, identify high ROI problems, prototype with low-code and GenAI solutions, and implement systems that pull the solution and operations towards the goal.

The ideal candidate is a structured problem solver with an eye for detail, a track record of rolling up their sleeves to experience the problem, and excellent communication skills.

Duties and Responsibilities

• Define KPIs and build dashboards to measure performance and support proactive decision-making.

• Identify, structure, and prioritize problems that affect our KPIs. Use frameworks and data to brainstorm options. Facilitate tradeoff conversations with leadership to align on a recommendation.

• Create project plans, generate cross-functional buy-in, and project manage a team to meet deliverables.

• Build low-code solutions and otherwise prototype products. Use these prototypes to clarify product requirements for PMs and engineers.

• Implement processes and systems to reduce chaos and pull operations towards KPIs.

• Be a thought partner to our operations, product, and engineering leaders.

Qualifications

Education/Experience

• Bachelor's degree, ideally in a quantitative field like engineering, science, or mathematics.

• 5+ years of experience in a role that requires highly structured problem solving like engineering, consulting, finance, and supply chain management.

• Experience operating, building, or otherwise getting your hands dirty to solve the problem.

Skills

• Strong analytical problem solving and structured thinking. Able to translate ambiguity into repeatable and scalable systems.

• Thorough and detail oriented.

• Action-oriented and not afraid of solving a problem you've never seen before. A self-starter and go-getter.

• Comfortable building models in Excel or writing scripts in Python. Bonus points if you've built solutions with GenAI tools.

• Excellent communication skills and an ability to tailor your message to the audience.

• Collaborative and teammate-lifting mindset.

Not Specified
Sr Clinical Research Specialist
Salary not disclosed
Irvine, California 1 week ago

Kelly Science and Clinical FSP is currently seeking a Sr Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate client, procedures and guidelines, this position:

  • Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones.
  • Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
  • May serve as the primary contact for clinical trial sites (e.g. site management);
  • Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,....), ensure registration on from study initiation through posting of results and support publications as needed;
  • Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
  • Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
  • Oversee the development and execution of Investigator agreements and trial payments;
  • Responsible for clinical data review to prepare data for statistical analyses and publications;
  • If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
  • May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
  • If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
  • Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
  • Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
  • Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
  • Support project/study budget activities as assigned;
  • Develop a strong understanding of the pipeline, product portfolio and business needs;
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
  • Perform other duties assigned as needed;
  • Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.

EXPERIENCE AND EDUCATION*

Education

  • Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

  • BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
  • Previous experience in clinical research or equivalent is required.
  • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...).
  • Clinical/medical background a plus.
  • Medical device experience highly preferred
  • Class III Medical Device experience (implantable) preferred

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Functional and Technical Competencies:

  • Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
  • Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
  • Good presentation and technical writing skills;
  • Good written and oral communication skills;

Leadership Competencies:

  • Ability to lead small study teams to deliver critical milestones, as may be assigned.
  • Leadership required in alignment with J&J Leadership Imperatives:
  • Connect - Develop collaborative relationships with key internal and external stakeholders.
  • Shape - Make recommendations for and actively participate in departmental process improvement activities.
  • Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
  • Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

LOCATION & TRAVEL REQUIREMENTS

Primary location for this position is Irvine.

  • Ability to travel approximately 20% depending on the phase of the program.

EXTERNAL INTERACTIONS

  • Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
  • May have regular interaction with third party vendors supporting clinical studies as applicable per program.
Not Specified
Evidence & Learning Officer (18-month contract)
Salary not disclosed
Irvine, California 1 week ago

***Candidates must be based in California, Maryland, or DC.***

ABOUT SEQUOIA CLIMATE FOUNDATION

Sequoia Climate Foundation is a climate philanthropy that believes in a world powered by clean energy, where all people are protected by policies that have averted the worst effects of climate change. We support bold strategies and efforts that will have both near-term impact and the greatest probability of long-term success. We believe that solving climate change requires the adoption of ambitious, evidence-based policy solutions that transform markets, advance clean technology, and lead to large‐scale change.

JOB SUMMARY

The Evidence and Learning Officer implements evidence and learning practices, providing actionable, evidence-based insights to grantmaking staff. They provide support in the development of theories of change, and review proposed strategies and grants to support high impact grantmaking. They work closely with grantmaking teams, providing training on key evidence and learning practices, as well as ongoing coaching and implementation support. They support strategic reflection practices with both grantmaking staff and grantees, using established methods and approaches. They work across multiple grantmaking portfolios, and are able to adapt their modes of engagement to meet the needs of grantmaking staff. Where necessary, they engage directly with grant recipients on evidence and learning related topics. They foster and embody a culture of organizational learning. The Research Officer will report to the Chief Evidence and Learning Officer, and collaborate closely with grantmaking staff across multiple organizations.

ESSENTIAL JOB FUNCTIONS & KEY OUTCOMES

  • Collaborates with multiple grantmaking portfolios to support theory of change development and provide pragmatic reviews of proposed grantmaking (using established methods and protocols).
  • Supports grantmaking teams to implement purpose-oriented reflection practices with grantees that support grant stewardship and ongoing learning.
  • Supports implementation of structured processes for reflection and evidence-based briefings oriented toward distilling actionable insights that maximize climate impact.
  • Collaborates with other Evidence and Learning staff to conduct purpose-driven, pragmatic quantitative analysis in support of philanthropic decision-making.
  • Fosters and embodies a culture of iterative experimentation and learning internally and with partners.
  • Manages multiple projects and timelines
  • Performs other duties as required.

EDUCATION, EXPERIENCE & CREDENTIALS

  • Advanced degree in policy, science, engineering, or mathematics required.
  • A minimum of three years working in climate policy, climate philanthropy, or a related field is required.
  • Demonstrated experience with synthesizing and translating technical content into actionable insights delivered verbally or writing or verbally required.
  • Demonstrated experience with project management and coordination across a team required.
  • Knowledge of learning and reflection practices preferred.

COMPETENCIES

  • Integrity: Commitment to Sequoia Climate Foundation's mission and values.
  • Inspirational Leadership: Demonstrated values-based, results-driven leadership.
  • Collegiality: Strong work ethic and experience working collaboratively with a team.
  • Efficiency/Initiative: Ability to learn quickly, juggle multiple tasks, prioritize effectively and meet deadlines.
  • Quality/Compliance: Attention to detail and timelines.
  • Analysis: Comfortable applying mathematical concepts, including calculus, statistics, and Bayesian probability.

WORKING CONDITIONS

This is largely a sedentary position that requires the ability to speak, hear, see, and lift small objects up to 15 lbs. Requires the ability to periodically travel locally, regionally, nationally, and internationally.

contract
Engineering Project Manager
Salary not disclosed
Irvine, California 1 week ago

Job Title: Project Manager (Structural Engineering)

Location: Glendale, El Segundo, or Irvine, CA

Schedule: Monday-Friday (On-site)

Job Type: Direct Hire

Salary: Base pay starts at $90,000+

Overview:

A growing engineering firm is seeking an experienced Project Manager to support its structural engineering practice. This role is responsible for leading multiple projects, maintaining client relationships, and ensuring technical excellence from proposal through project completion.

Key Responsibilities:

  • Lead and manage multiple structural engineering projects simultaneously
  • Coordinate, prepare, and respond to RFPs, RFQs, and other client solicitations
  • Collaborate with the Principal-in-Charge on the development of structural systems
  • Serve as the primary point of contact for clients on project-related matters
  • Ensure technical accuracy, quality control, and compliance with project standards
  • Establish and manage project fees, budgets, and schedules in partnership with leadership
  • Monitor project costs and timelines to maintain profitability and meet contractual commitments
  • Identify out-of-scope work and prepare proposals for additional services
  • Report directly to the Principal-in-Charge
  • Perform Project Engineer duties when required

Qualifications:

  • Bachelor's degree in Civil Engineering, Architectural Engineering, or Structural Engineering
  • Structural Engineer (S.E.) license with 10+ years of experience preferred
  • Professional Engineer (P.E.) license with 3–10 years of project leadership experience considered
  • Demonstrated experience managing structural engineering projects
Not Specified
Clinical Studies Coordinator
🏢 Willow Laboratories
Salary not disclosed
Irvine, California 1 week ago

*Position only available on-site in Irvine, CA*

Job Summary:

We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation.

This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams.

This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes.

Key Responsibilities:

  • Lead the planning, coordination, and execution of clinical studies, including:
  • Pilot/feasibility studies
  • IDE-exempt and IDE-supporting studies
  • Pivotal and non-pivotal studies for FDA 510(k) submissions
  • Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
  • Real-world evidence (RWE) and usability studies
  • Develop and manage study timelines, milestones, and deliverables
  • Ensure studies are conducted in compliance with GCP,FDA regulations, ISO 14155 and other applicable standards.
  • Prepare, review, and maintain clinical documentation for regulatory submissions, including:
  • Clinical Study Plans (CSPs)
  • Protocols and amendments
  • Informed Consent Forms (ICFs)
  • Statistical Analysis Plans (SAPs) (in collaboration with biostatistics)
  • Clinical Study Reports (CSRs)
  • Ensure audit-ready clinical documentation at all times

Other Responsibilities:

  • Support subject recruitment and enrollment activities
  • Conduct blood draws on study subjects.
  • Process blood samples.
  • Initiate IV's when the MD is unavailable.
  • Supervise the maintenance of laboratory equipment, including calibration records.
  • Maintain clinical staff training documentation.
  • Perform other duties or special projects as requested.

Minimum Qualifications and Experience:

  • 7 – 10 years of related experience or equivalent combination of education and experience.
  • Excellent communication skills (both written and oral).
  • Knowledge of clinical databases and data management systems
  • Ability to be an integral part of an innovative, fast-paced product development team.
  • Ability to manage multiple concurrent studies is essential
  • LVN with IV training certificate or RN.

Preferred Qualifications:

  • Bachelor's degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering
  • Experience with clinical studies and interfacing with IRB.
  • Clinical research certifications

Physical requirements/Work Environment:

This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver's license is required. Some travel to clinical sites might be required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Not Specified
Workers Compensation Claim Manager
Salary not disclosed
Orange, California 1 week ago

Workers Compensation Claim Manager

Property & Casualty Insurance

The manager oversees a team of Claim Specialists who address claims of varying complexities within the department. This role involves tracking claim trends and regularly reporting findings to department leadership, along with action plans to mitigate any negative trends. Candidates residing in Pacific Standard Time regions are highly preferred. A deep understanding of California Workers' Compensation statutes is essential. The manager will direct policies and procedures to ensure that claim handling aligns with the company's best practices, as well as all relevant legal and regulatory standards.

Collaboration with the Assistant Vice President is a key aspect, focusing on the planning and establishment of regional business goals. Working alongside risk engineering, underwriting, account executives, vendor management, and legal teams, the manager will address trends that could affect claims costs and develop guidelines that support the department's and company's objectives. Technical support should be provided to claims specialists, drawing from industry publications, seminars, and various resources to remain current on essential updates.

Staying informed about recent legal rulings and trends by reviewing case law is also critical. Ensuring a competent claims staff is vital for the timely and equitable resolution of claims based on applicable contracts, state regulations, and company policies. Coverage issues will be identified, including a review of all coverage evaluation letters. The manager will approve recommendations for case reserves and oversee the adequacy of reserves for claims managed by the team. Guidance in claim negotiations and extending settlement authority to Claims Specialists is essential, as is recruiting, mentoring, and retaining skilled staff. Developing and training direct reports is important to maximize their growth and success, while also addressing any performance issues to meet both departmental and individual goals.

Setting, executing, and monitoring regional office claims objectives in alignment with the company's mission is crucial, along with a willingness to participate in special projects beyond standard duties. Engaging with current and potential customers about the company's claims capabilities and their specific needs is also required.

Candidates should have over eight years in WC Claims supervision or management roles, with substantial experience in California jurisdiction. A bachelor's degree or its equivalent is mandatory, alongside strong verbal and written communication skills. Proficiency in the Microsoft Office suite and Lotus Notes is also necessary.

Not Specified
Senior R&D Scientist - Atmospheric Water Harvesting
Salary not disclosed
Irvine, California 1 week ago
Senior R&D Scientist - Atmospheric Water Harvesting
Location: Irvine, CA
Join a trailblazing startup founded by a renowned Professor in transforming the future of water and air. As a Senior R&D Scientist, you'll be at the heart of pioneering technologies for atmospheric water harvesting and CO2 capture, driving innovations that make a global impact.
Why You Should Apply
  • Lead cutting-edge research in atmospheric water harvesting.
  • Competitive salary and benefits package.
  • Collaborate with top-tier scientists and engineers.
  • Play a crucial role in the commercialization of breakthrough technologies.
  • Contribute to sustainability and environmental solutions.
What You'll Be Doing:
  • Work with the head of Product Engineering to scale up MOF/COF-based technologies.
  • Collaborate with R&D scientists on technical and functional specifications.
  • Design and develop heat management systems, optimizing components like heat exchangers and thermal storage.
  • Scale technologies from prototype to commercial stage.
  • Optimize system parameters to enhance performance, efficiency, and safety.
  • Evaluate and manage sourcing of materials and components.
  • Set up QC/QA processes and procedures for production.
  • Maintain detailed electronic notebooks and contribute to intellectual property.
  • Report periodically to management and participate in technical meetings.
About You:
  • PhD in mechanical engineering or a similar field with a strong research background.
  • Proficient in thermodynamics, fluid mechanics, and heat transfer.
  • Over 5 years of industrial R&D experience.
  • Skilled in designing system-level prototypes and using simulation tools.
  • Familiar with health and safety procedures in production.
  • Excellent teamwork, problem-solving, and communication skills.
How To Apply
We'd love to see your resume, but we don't need it to have a conversation. Send us an email to and tell us why you're interested. Or, feel free to email your resume. Please include Job#19433.
Not Specified
Process Validation Engineer
Salary not disclosed
Irvine, California 1 week ago

About Company:

Who Are We?

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.

About the Role:

The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes operate within defined parameters and yield reliable, reproducible results. The engineer collaborates closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs to identify process risks and implement corrective actions. By analyzing process data and trends, the engineer supports continuous improvement initiatives that enhance process efficiency and product quality. Ultimately, this role ensures compliance with industry standards and contributes to the successful commercialization of products within the United States market.

Minimum Qualifications:

  • Bachelor's degree in Engineering, Science, or a related technical field.
  • 3+ years of experience in process validation within a regulated manufacturing environment.
  • Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, cGMP, ISO).
  • Experience with statistical analysis and process capability studies.
  • Excellent written and verbal communication skills.

Preferred Qualifications:

  • Master's degree in Engineering, Quality Assurance, or related discipline.
  • Experience in the pharmaceutical, biotechnology, or medical device industries.
  • Familiarity with automation systems and computerized system validation (CSV).
  • Certification in Quality or Validation (e.g., ASQ Certified Quality Engineer).
  • Proficiency with data analysis software such as Minitab or JMP.

Responsibilities:

  • Develop, review, and execute process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Collaborate with manufacturing and quality teams to identify critical process parameters and quality attributes.
  • Analyze process data to assess process capability and identify areas for improvement.
  • Prepare detailed validation reports and maintain comprehensive documentation in compliance with regulatory standards such as FDA and ISO.
  • Support investigations related to process deviations, non-conformances, and implement corrective and preventive actions (CAPA).
  • Participate in risk assessments and process design reviews to ensure robust and compliant manufacturing processes.
  • Train and mentor manufacturing personnel on process validation requirements and best practices.

Skills:

The Process Validation Engineer utilizes analytical skills daily to interpret complex process data and ensure manufacturing consistency. Strong communication skills are essential for collaborating with cross-functional teams and documenting validation activities clearly and accurately. Technical expertise in validation protocols and regulatory standards guides the development and execution of robust validation plans. Problem-solving skills are applied to investigate deviations and implement effective corrective actions. Additionally, proficiency with statistical tools and software supports data-driven decision-making and continuous process improvement.

Not Specified
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