Engineering Jobs in California
1,215 positions found — Page 64
Here, we craft excellence together. Your mission? Making the journey the most enjoyable part of the trip.
Join our first-class team to reinvent in-flight experience. In the role of Planning Supervisor, you'll play a pivotal part on our production team.
The Aftermarket Planning Supervisor will lead and manage a team of spares planners within the aftermarket division of a global aerospace manufacturing company. This role is dedicated to ensuring operational excellence in aftermarket planning, scheduling, and inventory management. With a strong focus on aerospace spares support, the Supervisor will oversee queue management, KPI performance, and daily planning execution to meet customer requirements. The position plays a key role in ensuring the accuracy of data in the business system, which directly impacts company-wide financial reporting and aftermarket customer satisfaction.
• Lead, mentor, and supervise a team of spares planners in the aerospace aftermarket division, ensuring high performance, accountability, and alignment with organizational goals.
• Implement and maintain world-class strategies for aftermarket planning, scheduling, inventory, and customer satisfaction, while driving continuous improvement across all functions.
• Oversee all aftermarket planning activities, including workload balance, prioritization, and queue management for PPO, initial commitment dates and recovery dates, ensuring accuracy, timeliness, and ownership of all lines.
• Drive daily execution of key aftermarket KPIs including PPO release adherence, initial commitment dates and recovery date creation, and PMO release compliance. Monitor individual performance, flex resources to balance changing workloads, and lead cross-functional efforts to resolve the highest aging lines.
• Act as the first line of escalation for planning and operational issues, providing rapid problem-solving support to both the team and internal stakeholders.
• Maintain and update weekly KPI charts for Tuesday management reports, providing analysis and insights while the Manager presents. Transition ownership of additional metrics (supply cancellations, pull-ins, pushouts, NCR, etc.) from Manager to Supervisor over time.
• Develop and monitor aftermarket production plans, budgets, and schedules in line with aerospace requirements and plant capacity. Proactively identify risks or delays and implement corrective actions to protect customer commitments.
But what else? (advantages, specificities, etc.)
• Ensure planners execute essential functions including BOM analysis, material planning, timely requisition delivery to purchasing, work order release and management, revision control, ERP data accuracy, and on-time fulfillment of aftermarket customer requirements.
• Oversee inventory levels to meet company and aftermarket customer goals, ensuring alignment with financial targets and operational needs.
• Foster premier customer service for airlines, MROs, and other aerospace aftermarket clients by ensuring planning execution supports client expectations.
• Conduct risk assessment and mitigation activities specific to aftermarket supply chain challenges.
• Provide leadership through training, mentoring, and talent development, driving a culture of accountability, collaboration, and professional growth within the spares planning team.
• Execute strong working knowledge of MRP/ERP systems and other applicable planning tools, leveraging aerospace expertise to optimize performance.
• Collaborate with supply chain, operations, engineering, and quality teams to ensure aftermarket planning alignment with aerospace manufacturing standards and long-term business objectives.
• Other duties as assigned by the management team.
Candidate skills & requirements
Education: BS/BA degree required from an accredited university
Experience: Minimum of 7+ years of progressive planning, scheduling and inventory management experience in aerospace, automotive or mechanical manufacturing environment with the ability to lead and influence others, with 2+ years of the 7 years in a planning leadership position
Computer Skills:
• Experience working with MRP/ERP systems
• Proficiency with MS Office Skills (Excel, Word, PowerPoint, Outlook)
Other Skills:
• Broad knowledge of the field with proven management skills.
• Effective oral and written communications skills
• Demonstrated ability to handle multiple projects and assignments with attention to detail
• Problem solving, well organized, detailed oriented and accurate.
• Strong written and verbal business communications abilities must be comfortable delivering information to all levels of the organization including senior leadership.
• Working knowledge of business finance skills and abilities.
Additional Preferred Skills: (not required)
• BS/BA in supply chain, business management, or operations from an accredited university
• APICS CPIM and/or ISM certifications
• Experience in AS/ISO standards quality management experience.
• Problem-solving skills (Six Sigma Green Belt, etc.)
• Aftermarket or Spares Business experience
Description: Entry-level management position within field.
OCCUPATIONAL SUMMARY
Responsible for the overall safe and efficient plant operations of Gillibrand Industrial Sands, Inc. Manages and directs the activities of production, quality control and implements the strategy for the facility. Manages the operations associated with Industrial Sand and aggregate production, including quarrying, mining, processing, quality control, stockpiling, loading and shipping. Responsible for Environmental, Health and Safety (EHS) aspects of the facility, fixed and mobile equipment maintenance, and employee relations.
JOB DUTIES:
Operations Management:
· Oversee all aspects of Industrial Sand / Aggregate plant operations, including crushing, screening, washing, and material handling.
· Schedule and manage daily production to meet quality and volume targets.
· Monitor equipment performance and coordinate routine maintenance and repairs.
· Plans and schedules production requirements (people & equipment) to support daily, weekly, monthly, quarterly and annual sales forecast to meet customer’s needs.
· Identifies, assesses, prioritizes, and resolves production and employee-related problems.
· Manages production meetings on the daily operations of the plant.
· Walks throughout the operation daily and ensures the cleanliness of the entire facility.
Personnel Management:
· Manages and supervises activities of salaried and hourly production and maintenance employees.
· Actively involved in the selection, hiring, training, change of status, and separation of employees.
· Supervise, train, and evaluate plant staff (operators, technicians, laborers).
· Enforce company policies and safety protocols.
· Coordinate shift schedules and manage labor resources efficiently.
· Provides coaching and disciplinary counseling to employees under his or her area of responsibility (includes employee relations and administration of collective bargaining agreements region specific).
· Administers and enforces Company policies and procedures.
Safety & Environmental Compliance:
· Ensure adherence to MSHA, OSHA, and environmental regulations
· Conduct regular safety meetings, inspections, and incident investigations.
· Implement and maintain site-specific safety programs. Ensures that the plant meets all EHS policies and practices at the site location and works with EHS Regional employees and Company officials to promote a safe work environment that meets all State and Federal rules and regulations.
· Ensures that employees receive proper training and instructions to perform assigned job duties.
· Utilizes appropriate resources and recommendations in community relations and legislative efforts and actively participates in the area’s community outreach and educational programs.
Quality Assurance:
· Ensure product meets customer specifications and internal quality standards.
· Work closely with the quality control team to address deviations.
· Works closely with sales staff, quality control personnel, and customers to ensure that products meet customer needs and expectations.
· Works with sales on identifying and eliminating customer issues and concerns to improve customer satisfaction and relations.
· Participates in developing an annual operating budget, which includes production volume, maintenance expenses, and maintenance of business assets (replacement and critical spares), along with capital improvements.
Budget & Reporting:
· Manage the operating budget, track production costs, and seek cost-saving initiatives.
· Maintain accurate production records, maintenance logs, and compliance reports.
· Provide regular performance updates to senior management.
· Manages plant production operations to ensure cost efficiency, optimal plant and equipment utilization, and personnel allocation.
· Responsible for ensuring that the site meets or exceeds operating budget.
· Participate in Operation’s short- and long-range business planning.
Continuous Improvement:
·Identify and implement process improvements for efficiency and productivity.
·Support capital projects and equipment upgrades.
· Works on implementing cost-saving programs and/or continuous improvement activities to reduce costs and improve operating efficiency.
· Compiles data and provides information to analyze and recommends more cost-effective and technologically advanced methods of production processes.
QUALIFICATIONS
· BS degree in Engineering (Mining/ Civil, Mechanical/ Materials/ Mineral Processing); preferred or an equivalent combination of education and experience.
· Minimum of 5 years’ prior work experience in supervising production employees, preferably at either an Industrial Sand or Industrial Minerals mine. Construction materials industry experience preferred
· Knowledge and understanding of modern principles and practices of supervising production employees
· Thorough knowledge of plant operations and their associated products, processes, and related equipment.
·Strong knowledge of crushing, screening, separation, and material handling equipment.
· Knowledge of safety and environmental rules and regulations (MSHA and OSHA).
· Knowledge and understanding of business planning and financial forecasting requirements.
· Excellent leadership, communication, organization, conflict, and problem resolution skills.
· Proficient in Microsoft Office Suite and other software packages relevant to the position.
· Ability to plan and manage effectively using motivation and team-building skills.
· Flexible to work long hours and occasional overnight travel.
· Must represent the company in a professional manner to all customers, vendors, and internal employees.
· Other duties may be assigned as required
WORK DEMANDS AND ENVIRONMENT
· Personal protective equipment is required on a regular basis, as needed, including hard hat, hearing protection, eye protection, hard-toed safety shoes or boots, dust mask respirator, protective clothing, gloves, and other personal protective equipment.
· Employee may be exposed to dusty and noisy environments and may be working occasionally in extreme weather conditions including heat, cold, wind and rain.
· Work environment will be both indoors in an office and outside in the quarry or plant.
· In the office, will occasionally be required to sit at a desk or operator’s station. In the outside setting, will perform activities at various heights around moving machinery, be exposed to dust, fumes, and gases; may be required to use hand or power tools.
·Must be able to lift 50 lbs. and walk across uneven surfaces.
· Must have a valid driver’s license.
3 Entry Level Manufacturing Engineers - base salary $70,000 - $75,000 per annum plus benefits
2 Mid Level Manufacturing Engineers - Base salary $80,000 - $84,000 per annum plus benefits.
1 Senior Manufacturing Engineer - Base Salary $86,000 - $90,000 per annum plus benefits.
The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:
What You Will Do:
- Create and maintain standard work to improve the accuracy, speed, and efficiency of production processes.
- Develop and deliver comprehensive training programs to educate employees, teams, and stakeholders on Lean methodologies, tools, and principles.
- Review and refine operations to standardize workflows and ensure best practices are implemented for maximum efficiency.
- Plan, facilitate, and execute Value Stream Mapping (VSM) activities to identify current-state processes, bottlenecks, and areas of improvement across the value stream.
- Update, maintain, design, and communicate layouts of factory work cells based on Continuous Improvement (CI) principles, supporting the Sales and Operations Planning (S&OP) factory site plan.
- Collate data from various sources including ERP software.
What You Will Bring:
- Bachelor’s degree in mechanical engineering or similar STEM discipline.
- In absence of a degree, must have 9 years of relevant experience.
- 5+ years of manufacturing experience including Lean principles.
- Experience with equipment and factory layouts.
- Problem-solving skills with ability to proactively identify alternate solutions to overcome difficult technical challenges.
- Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams to achieve operational goals.
- Detail-oriented and capable of managing multiple priorities in a fast-paced environment.
Work Requirements:
This is a fulltime and 100% on-site role located in Riverside, CA
- You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours.
- Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.
Travel requirements:Due to the nature of the work, zero travel is required.
WHO WE ARE
Together we are a world-class diversified manufacturer with a commitment from our team to proudly provide pure precision solutions to our customers, delivering superior quality, value, and service.
Ferrotec (USA) Corporation is a technology company with a worldwide presence in various end products, manufacturing systems, and industries serving primarily the semiconductor industry. We provide our customers with advanced materials, components, systems, and manufacturing solutions. Please visit for a list of office locations.
HOW YOU MAKE AN IMPACT
Automation Engineer II has the responsibility and skills to specify, develop, modify, test, troubleshoot, document, and deploy new or existing control system and related software for Ferrotec products, internal scientific research, and to support other goals. Assigned projects will have timeframes ranging from short tasks of a few hours to development efforts on the order of months. In addition, this role continuously assists customers with automation equipment and software issues, most-often remotely, and generally with limited or incomplete information. Collaboration with other team members will be frequent, but professional experience enables Automation Engineer II to be productive with greater independence.
WHAT SUCCESS LOOKS LIKE
- Specify, develop, modify, test, troubleshoot, document, and deploy new or existing control system and related software for Ferrotec products, internal scientific research, and other company objectives.
- Startup, troubleshoot, and repair existing, new, or upgraded control systems, including soft logic, human/machine interface, wiring, and hard logic. Mark-up schematics, if applicable; document problems and solutions to improve next startup cycle for self and others.
- Perform engineering development activities in a manner consistent with established conventions, producing work products compliant with departmental standards and expectations.
- Seek opportunities to add value to products or reduce recurring costs by advancing designs with new technology, improved processes, and procedures, or by other means in a cost-justified manner.
- Communicates changes and documents requirements, defines scope and objectives for the generation of documentation, procedures, logs, and instructions, both for internal and external consumption.
- Compiles key project-relevant information from vendor documentation and recommend course of action.
- Create software specifications for larger changes and projects
- Ability to identify problems and root causes, then quickly resolve.
- Performs other related duties as may be reasonably assigned in the course of business.
Not a comprehensive list of duties. Duties may change without notice at management’s sole discretion
WHAT YOU NEED TO BE SUCCESSFUL
- Degree in Engineering with an emphasis in embedded control, automation, and computer programming.
- 2 to 4 years of relevant work experience
- Programming languages:
- C# - For low level programming
- TwinCat/Ladder logic - PLC programming
- XML - Configuration
- XAML - Screen control
- Robotics integration
- Teamwork and communication
Preferred Skills:
Systems Thinking
- Holistic View: Systems thinking is the ability to see the big picture and understand how different parts of the system interact. As an automation engineer, you need to understand how automation in one area might affect other parts of the system.
- Feedback Loops: Recognizing feedback mechanisms within a system is essential. For example, if an automated task fails, it’s important to understand how the system should react and whether alerts or retries are needed.
- Reliability and Redundancy: Designing automation that ensures reliability and fault tolerance in systems. Ensuring that systems can recover from failures or errors without affecting the overall process is crucial.
PERKS OF JOINING OUR TEAM
With positive values, a productive atmosphere, and a commitment to excellence, Ferrotec encourages employees to maximize and realize their potential.
The salary range included in this job posting is relevant to applicants who reside or work in the Livermore, CA area only. Salary offers will depend on experience, knowledge, skills, education, and location. Actual salary may vary due to these and other factors.
Ferrotec is proud to offer a Competitive Benefits Package including Medical, Dental, Vision, Life & Disability, 401K Matching, Flexible Work Hours, Tuition Reimbursement, Leadership Development, Travel and Hotel Discounts, Paid Time Off, Sick & Wellness and Volunteer Time, Employee Recognition Program, Employee Engagement & Appreciation Events hosted throughout the year. Virtual Wellness Activities and Classes are available to all employees & family members and Much More!
We would love to get to know you better and you get to know us better! You can easily apply!
We are proud to be an Equal Opportunity and Affirmative Action employer and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other protected factor under federal, state or local law.
Construction Quality Control (QC) Manager – San Diego County, CA
$100,000 – $150,000 + Vehicle Allowance, Bonus & Full Benefits
Federal Contractor | DoD & USACE Projects | Long-Term West Coast Opportunity
We are representing a respected federal Design/Build contractor in their search for an experienced Construction Quality Control (QC) Manager to support military and federal projects across San Diego County, California. This firm has a strong reputation for delivering highly regulated projects to the highest standards of quality, safety, and compliance and offers long-term career growth within their West Coast operations.
This is a fully on-site leadership role, ideal for a QC professional who thrives in compliance-driven environments and takes pride in delivering right-first-time construction.
The Role:
As the Quality Control Manager, you will be responsible for implementing and overseeing project-specific QC programs while serving as a key liaison between field teams and federal clients.
Responsibilities include:
- Plan, coordinate, and implement QC programs in accordance with contract and federal requirements
- Ensure all QC documentation, reporting, and administrative tasks are completed accurately and on schedule
- Monitor field operations to ensure work quality, safety, and environmental compliance
- Support project teams with inspections, corrective actions, and compliance oversight
- Represent the company professionally while building strong client and stakeholder relationships
What We’re Looking For:
- Bachelor’s degree in Engineering, Architecture, Construction Management, or related field (or equivalent experience)
- 5–10 years of construction experience, including 2+ years in a dedicated QC Manager role
- Active USACE CQM for Contractors certification (required)
- Proven experience on military, federal, or highly regulated projects
- Strong documentation, reporting, and organisational skills
- Confident communicator with the ability to work directly with federal clients
Desirable:
- Specialty inspection certifications
- LEED accreditation
- OSHA 30, EM 385-1-1, CPR/First Aid certifications
- Experience with Vista/Viewpoint software
- Willingness to obtain additional certifications (training available)
What’s in It for You:
- Competitive salary ranging from $100,000 – $150,000, depending on experience
- Vehicle allowance and bonus eligibility
- Comprehensive benefits package including medical, dental, vision, PTO, and holidays
- Career advancement within a leading federal Design/Build contractor
- Stable pipeline of Department of Defense and federal projects
Interviews are actively underway, so if you’re interested in learning more, please get in touch as soon as possible to discuss further at (48 or send your resume to
ANEUVO is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.
We are currently looking for a detail-oriented and reliable Production Operator / Technician to join our manufacturing team in producing high-quality medical devices. You will be responsible for operating equipment, assembling components, inspecting products, and ensuring adherence to strict regulatory standards such as ISO 13485 and FDA cGMP.
Key Responsibilities:
- Operate and monitor production equipment according to SOPs (Standard Operating Procedures)
- Assemble medical device components manually or using automated tools
- Perform in-process inspections and testing to ensure product quality
- Maintain accurate records of production output, defects, and downtime
- Follow Good Manufacturing Practices (GMP), cleanroom protocols, and safety guidelines
- Participate in root cause analysis and continuous improvement activities
- Support equipment maintenance, calibration, and troubleshooting
- Collaborate with quality, engineering, and warehouse teams to meet production goals
Qualification:
- High School diploma or GED required; Associate degree or technical certification preferred
- 3 to 5 years of experience in a manufacturing environment, preferably medical device or pharmaceutical
- Basic knowledge of GMP, ISO 13485, and cleanroom standards
- Ability to read technical drawings, work instructions, and production schedules
- Strong attention to detail and manual dexterity
- Ability to stand for long periods and lift up to 30 lbs
- Comfortable working in controlled environments
Preferred Qualification:
- Experience with medical device assembly
- Familiarity with electronic batch records (EBR) and ERP systems
- Ability to work effectively in a team-oriented, fast-paced environment
- Good written and verbal communication skills
What we offer:
- A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
- A unique environment for you to exercise your talents and be impactful
- Medical, dental and vision insurance
- Employee stock options
Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.
Sequoia Living – San Francisco High-Rise Community
Sequoia Living is seeking an experienced, mission-driven Director of Environmental Services to lead operations in our high-rise community. This is a highly visible leadership role responsible for creating a safe, clean, efficient, and beautifully maintained environment for the residents who call our community home.
If you are a hands-on, solutions oriented facilities professional who thrives in a dynamic environment and you are passionate about leading teams, elevating service standards, and improving the daily lived experience of residents this is a unique opportunity to make a meaningful impact.
Experience in a CCRC, senior living, healthcare, assisted living, or hospital setting is required.
Why This Role Matters
As the Director of Environmental Services, you are the operational backbone of the community. You ensure residents live in a well-maintained, safe, and welcoming environment while leading a diverse and dedicated team across plant operations, maintenance, housekeeping, laundry, landscaping, safety, and construction oversight. Your work directly impacts resident experience, staff satisfaction, regulatory compliance, and long-term asset preservation.
What You’ll Do (Key Responsibilities)
Leadership & Department Oversight
- Lead all Environmental Services functions, including plant operations, maintenance, housekeeping, laundry, landscaping, and safety programs.
- Recruit, hire, mentor, and develop supervisors and frontline staff; foster a culture aligned with Sequoia Living’s Mission, Vision, Values, and Commitment to Inclusion.
- Manage administrative operations, staff schedules, training, coaching, and performance review processes.
Facility Operations & Maintenance
- Oversee the community’s preventative and corrective maintenance programs, ensuring compliance with all Federal, State, and local regulations (EPA, ADA, OSHA/OSHPD, Titles 8, 19, 22 & 24).
- Review maintenance projects, repairs, and inventory needs; recommend improvement plans to community leadership and the Director of Design & Construction.
- Ensure the community’s safety programs (Fire, Disaster, Emergency Response, Hazardous Materials Plans) are up-to-date and fully implemented.
- Train staff in safe work practices, including asbestos and industrial chemical handling.
Construction, Capital Projects & Renovations
- Manage capital project planning and execution, including apartment renovations, building upgrades, and major infrastructure improvements.
- Maintain computerized capital budget tools, plan expenditures, and ensure timely project completion.
- Solicit and evaluate contractor bids; manage vendor relationships, permits, and certificates of insurance.
Budgeting & Resource Management
- Prepare and manage operating and capital budgets; track expenses and ensure cost control.
- Oversee energy conservation and utility monitoring to optimize efficiency.
Resident & Community Engagement
- Serve as a responsive partner to residents and committees on maintenance needs and special projects.
- Communicate professionally and collaboratively with department heads, staff, vendors, regulatory bodies, and Sequoia Living leadership.
Risk, Safety & Compliance
- Act as the community’s Safety Coordinator: oversee workplace safety programs, ensure incident reporting, support workers’ compensation processes, and lead safety initiatives.
- Identify and report resident concerns related to physical, mental, or emotional well-being.
- Participate in on-call rotation and support emergency response as needed.
What You Bring (Qualifications)
Experience
- 6+ years of hands-on experience in environmental services, facilities management, plant operations, or maintenance preferably in healthcare, senior living, or a residential community.
- 3+ years of supervisory or management experience leading diverse teams.
- Prior experience with building systems (HVAC, boilers, refrigeration, electrical/mechanical systems, automation, and life/safety equipment).
- CCRC or healthcare environment experience strongly preferred.
Education
- High school diploma required; 2+ years of college or trade school coursework in engineering, facilities management, or environmental services preferred.
- Bachelor’s degree in Engineering, Facilities Management, or related field strongly preferred.
Key Knowledge & Skills
- Regulatory & Compliance: Deep understanding of building codes, construction regulations, OSHA/OSHPD, Titles 8, 19, 22 & 24, ADA, and environmental compliance.
- Technical Proficiency: Ability to read blueprints, technical manuals, and schematics; strong understanding of HVAC, plumbing, electrical, carpentry, and mechanical systems.
- Safety & Risk Management: Expertise in workplace safety, hazardous materials handling, emergency response, and risk mitigation.
- Operational Excellence: Skilled in housekeeping, maintenance, landscaping, sanitation, and environmental cleaning standards.
- Project Management: Strong planning, scheduling, and vendor management experience.
- Technology Skills: Proficient with Microsoft Office and capable of learning maintenance, inventory, and HR systems.
- Communication & Leadership: Collaborative, calm under pressure, resident-centered, and able to lead with empathy and professionalism.
Why Work at Sequoia Living?
- A mission-driven organization devoted to enriching the lives of older adults.
- An opportunity to lead a critical operations team in an established and respected nonprofit community.
- A collaborative culture where your expertise directly shapes resident safety, comfort, and quality of life.
- A role with variety, challenge, and the ability to influence long-term building health and operational excellence.
Ready to Make an Impact?
If you are a proactive leader who finds purpose in maintaining exceptional environments, developing strong teams, and ensuring operational excellence we encourage you to apply. Join a community that values integrity, compassion, and innovation.
Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.
Job Title: QA Validation Specialist (Contract)
Duration: 10 months
Location: Irvine, CA (onsite)
Rate: $38–40/hr.
This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.
RESPONSIBILITIES:
- Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
- Authors/approves and executes qualification protocols and reports.
- Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
- Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
- Qualification of Vendors Selected.
- Input to the development of the URS/FRS/DDS.
- Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
- May present qualification studies to Regulatory and Client Auditors as required.
- Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
- Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
- Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
- Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
- Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
- Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
- Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
- Bachelor’s degree in Sciences
- 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
- Strong working knowledge of cGMP and regulatory standards for validation.
- Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
- Demonstrated experience with qualification of commercial processing a packaging equipment.
- Proven track record of managing projects from start to finish on time and on budget.
What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
This is a six month assignment in Vacaville
This potsition is for local candidates as there is no travel and living expenses
This is a W2 Position.
Process Engineer I
Summary:
This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.
In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.
Job Duties:
Responsibilities/activities may include, but not limited to:
• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).
• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.
• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.
• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.
• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.
• Reviewing and interpreting instrument data to identify basic trends or abnormalities.
• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.
• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.
• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.
• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.
Education and Experience:
• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.
• Prior hands-on experience with analytical systems is required.
• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.
Knowledge/Skills/Competencies:
• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
• General understanding of biotech analytical methods and laboratory practices.
• Experience troubleshooting analytical instruments and interpreting equipment performance data.
• Flexibility in problem solving and work hours to meet business objectives.
• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.
• Ability to work independently and manage assigned tasks with limited supervision.
• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.
• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.
• Ability to build productive working relationships with end users and equipment vendors.
• Strategic thinking mindset with the ability to convert system needs into actionable activities.
• Builds productive relationships with partners; focuses on customer needs.
Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.
Job Description: High-Throughput Screening Research Associate II, III (Biodesigner II, III)
Responsibilities:
- Perform massively parallel reporter assays and high-throughput screens across diverse cellular contexts using cellular and molecular readouts.
- Develop and execute molecular biology workflows such as vector design and cloning, DNA/RNA extraction, RT-PCR, qPCR, and next-generation sequencing.
- Support cell culture activities and experiments in multiple cell lines, at small and large scales.
- Design and execute cell-based assays (AAV/lentiviral transduction, transfection, flow cytometry, immunostaining, and other plate reader assays).
- Engineer and characterize cell-based systems using synthetic biology tools and techniques.
- Conduct and troubleshoot experiments, independently and in collaboration with colleagues, to optimize screening throughput, sensitivity, and specificity.
- Proactively troubleshoot technical issues and recommend potential corrective actions based on personal observations and literature searches.
- Prepare summaries of data and present internally to colleagues and management.
- Draft SOPs, follow protocols, diligently document experimental data in lab notebooks, and organize and maintain electronic work records.
- Author scientific reports and data summaries.
- Collaborate with cross-functional teams to meet project goals, bridging early discovery with high-throughput screens to nominate and optimize candidates for further characterization.
Qualifications:
- Bachelor’s or Master’s degree in Biology, Biochemistry, Chemical Engineering, Biological Engineering, or a related field.
- At least 2 years of industry wet lab experience.
- Mammalian cell culture experience (culturing, transfecting and transducing cells, and DNA/RNA purification from cells).
- Molecular biology expertise (vector design and cloning, qPCR, primer and probe design, DNA/RNA extraction workflows)
- Critical thinker with excellent communication skills who thrives in a multidisciplinary, fast-paced team environment.
- Strong written and verbal communication skills.
Preference will be given to those who display:
- High throughput screening assay development in an industry setting.
- High motivation, with a strong work ethic and dedication to generating impact.
- Attention to detail, with the ability to extract deep insights from data.
- First-principles thinking, and an ability to refine one’s intuition based on additional data.
- Ability to go from ideation to data in an independent fashion.
- Long-term personal vision with defined career goals.
- High EQ with team-oriented thinking.
- Experience with pooled, high-throughput screens using next-generation sequencing-based readouts, and/or preparing screening plasmid libraries from synthesized oligo arrays.
- Experience with CRISPR-Cas systems and/or gene editing and delivery technologies.
- Experience preparing next-generation sequencing libraries (Illumina, PacBio, and/or Nanopore platforms).
If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.
Please apply directly through LinkedIn.
Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.