Engineering Jobs in Orange, CA

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.

*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.

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.

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.

Who We Are

We are Skybound.

We love creators. We love fans. We love thrilling games, indelible images and moving stories. Our roots are in comics, but our brands extend to video games, television, movies, merchandise, and live experiences. We take special pride in original tales, fresh characters, and diverse voices.

From well-known franchises to freshly-minted originals, we offer the chance to join brilliant creators shaping a new generation of entertainment in a concentrated, agile environment where every perspective matters, and any idea can create a breakthrough.

Opportunity

Skybound is looking for an experienced and passionate Senior Systems Designer to help build a thrilling new game franchise. The Senior Systems Designers create rewarding loops that help players set goals, progress, and stay engaged over multiple play sessions. They craft and tune player advancement and rewards across the entire game.

You will collaborate closely with the Game Director, department leads, and cross-disciplinary teams to define and drive the strategic vision for player progression and meta systems. You'll mentor other designers, establish best practices, and ensure the systems design team delivers high-quality, scalable solutions that support both gameplay and business goals.

If you're passionate about building compelling systems, love mentoring others, and thrive in a creative, combat-focused environment, we'd love to hear from you.

Reports: This position will report to Game Director.

Responsibilities: Responsibilities include, but are not limited to:

• Lead the vision and execution of player progression, meta systems, and engagement loops across single and multiplayer experiences.
• Define and drive KPIs for progression systems that align with player satisfaction and business goals.
• Mentor and guide systems designers, fostering a culture of excellence, collaboration, and innovation.
• Own major feature areas from concept through implementation, ensuring quality and consistency across the game.
• Collaborate cross-functionally with engineering, art, UX, and production to ensure systems are well-integrated and technically feasible.
• Establish and evangelize best practices for systems design, documentation, and tool usage.
• Anticipate and resolve design challenges, proactively improving workflows and pipelines.
• Playtest and iterate on systems regularly, using data and player feedback to refine and optimize.

Requirements

• 10+ years of experience in the games industry, with a focus on systems design and progression.
• Proven leadership experience, including mentoring designers and leading cross-functional initiatives.
• Shipped at least one AAA title with significant ownership of progression or meta systems.
• Deep understanding of player psychology, engagement strategies, and content pacing.
• Strong analytical skills, with the ability to translate complex systems into clear, actionable designs.
• Experience collaborating with engineering on tool development and pipeline optimization.
• Excellent communication and documentation skills, with fluency in PowerPoint, Word, Excel, Visio, etc.
• Strategic mindset, balancing creative vision with technical and business constraints.

Preferred Qualifications

• Experience with Unreal Engine, including scripting and integration into production pipelines.
• Strong technical scripting skills and a willingness to learn new tools and technologies.
• Passion for combat-oriented games, player progression, and Skybound's unique properties.

Job Type: Regular, Full-Time

Salary Range: $125,000 - $165,000

• Actual base salary is dependent on several factors including but not limited to: market dynamics, location and region, experience, specialized skills/training (education), level of responsibility, budgetary considerations, tenure at the company (for current employees), etc.
• The salary range listed is just one component of the total compensation package for employees
• Compensation decisions are dependent on circumstances of each role

Skybound offers a wide array of benefits including medical, dental, vision, life insurance, flexible spending and dependent care accounts, as well as free counseling through our Employee Assistance Program (EAP). We also offer a 401K plan with 4% match, 12 weeks of paid parental leave, generous time off, wellness benefits, and tuition reimbursement.

Company Overview

Skybound is a multiplatform content company working closely with creators and their intellectual properties, extending stories and universes to new platforms, including comics, television, film, tabletop and video games, books, digital content, events, and beyond. We are home to critically-acclaimed global franchises, including The Walking Dead and Invincible.

Skybound Games produces, publishes and distributes video and tabletop games across all genres, including the multi-million-unit selling The Walking Dead video game series. In addition to our wholly-owned franchises, we work with independent developers to foster and create original games with compelling characters and worlds, strong creator and artistic focus, and innovative approaches to engaging genres.

Invincible is one of Skybound's tentpole franchises (celebrating 20 years!) and spans the world of comic books, merchandise, video games, and the critically acclaimed adult animated television series on Prime Video. Now in its second season, the television show has consistently ranked as one of Prime Videos top-streamed series with a 99% score on Rotten Tomatoes. Based on the groundbreaking comic book by Robert Kirkman, Cory Walker, and Ryan Ottley, Invincible revolves around 18-year-old Mark Grayson, who's just like every other guy his age—except his father is (or was) the most powerful superhero on the planet. Still reeling from Nolan's betrayal in Season One, Mark struggles to rebuild his life as he faces a host of new threats, all while battling his greatest fear - that he might become his father without even knowing it.

The show stars Steven Yeun, with Sandra Oh, Zazie Beetz, Grey Griffin, Chris Diamantopoulos, Walton Goggins, Gillian Jacobs, Jason Mantzoukas, Ross Marquand, Khary Payton, Zachary Quinto, Andrew Rannells, Kevin Michael Richardson, Seth Rogen, and J.K. Simmons. Executive producers include Skybound's own Kirkman, David Alpert, and Margaret M. Dean.

Equal Opportunity Employer

At Skybound we value diversity and are looking for extraordinary employees of all backgrounds! Skybound is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, citizenship, age, genetic information, disability, hair texture or veteran status. In addition to federal law requirements, Skybound complies with all applicable state and local laws governing nondiscrimination.

Skybound will consider applicants with criminal histories in a manner consistent with the CA Fair Chance Act and Los Angeles Fair Chance Initiative for Hiring Ordinance.

For more information on our Privacy Policy, visit: working/work at home options are available for this role.

***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.

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

*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.

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.

JOB OPENING - PLUMBING ENGINEER & PROJECT MANAGER

We are a full-service MEP engineering and consulting company. We are servicing the building industry in mechanical, electrical, and plumbing engineering services for different building types such as single-family custom homes, multifamily, mid-rise, high-rise, commercial, office spaces, retail, restaurants, mixed-use, and industrial. We have an opening for Plumbing Engineer &/or Project Manager who can handle the following responsibilities.

• Design of residential and commercial plumbing systems including calculations, piping layout, riser diagrams, equipment schedules, and details

• Coordination of the plumbing plans per developer, builder, architect, civil engineer, and other disciplines plans and requirements.

• Attending design and coordination meetings daily.

• Managing the project from schematic design (SD) phase all the way through the final stages of construction administration (CA).

• Designing the plans using AutoCAD & REVIT

REQUIREMENTS

• Bachelor of Science in Mechanical Engineering or equivalent experience

• Plumbing Design and Project Management experience, 2-6 years (preferred)

• Experience in AutoCAD & REVIT

• Microsoft Office

• Team player and detail oriented

COMPENSATION

• Salary Range: $65K-$75K

• Bonuses

BENEFITS

• Health insurance

• 401K

• Paid time off

• Paid vacations

• Paid sick time

SCHEDULE

• Monday-Friday 8:00 am - 5:00 pm

Partial remote work can be offered, depending on capabilities and upper management approval.

JOB TYPE

• Full Time

Interested applicant should forward resume to: