Top 7 Quality engineer medical device Jobs in Vacaville, Ca

Senior Validation Engineer - CSV (OT)
Lonza —Vacaville, CA
- $93,000 - $155,000 a year
- Full-time
- Computer Science
- 5 years
- Engineering
- Disability insurance
- Health insurance
Project Engineer 2-3
Concuir —Vacaville, CA
- $100,000 - $150,000 a year
- Full-time
- Bachelor of Science
- Engineering
- Mid-level
- Commuter assistance
- Disability insurance
Test Engineer
Elve Inc —Davis, CA
- $85,000 - $125,000 a year
- Full-time
- Engineering
- Data analysis skills
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Power System SCADA and Controls – Specialist / Engineer
SEL Engineering Services, Inc. —Vacaville, CA
- $115,300 - $170,400 a year
- Full-time
- Bachelor of Science
- Mid-level
- Travel
- Paid holidays
- Disability insurance
Quick Apply
Senior Mechanical Engineer, Applications & Automation
CKC Automation LLC —Benicia, CA
- $140,000 - $170,000 a year
- Full-time
- 7 years
- Mentoring
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
Quick Apply

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quality engineer medical device jobs near vacaville, ca

Senior Validation Engineer - CSV (OT)

Lonza -
Vacaville, CA

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Job Details

Full-time
$93,000 - $155,000 a year

Benefits

Disability insurance
Health insurance
Dental insurance
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance

Qualifications

Automation
Manufacturing facility experience
Production validation processes
Pharmaceutical company experience
Manufacturing
Building automation systems
Pharmaceutical manufacturing facility experience
Continuous process control systems

Full Job Description

Location: Vacaville, California

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

The full-time base annual salary for this position is expected to range between $93,000 to $155,000. In addition, below you will find a comprehensive summary of the benefits package we offer:

Performance-related bonus
Medical, dental and vision insurance
401(k) matching plan
Life insurance, as well as short-term and long-term disability insurance
Employee assistance programs
Paid Time Off

The Senior Validation Engineer - CSV at Lonza will be responsible for leading and executing validation activities for manufacturing processes, equipment, computerized systems, and automation control systems to ensure compliance with regulatory requirements and internal quality standards. This role requires a strong understanding of cGMP principles and a proven track record in a pharmaceutical or biotechnology manufacturing environment.

What you will do:

Responsible for oversight and performance of Commissioning and Qualification of computerized equipment, utility systems, facilities, automation control systems, and site computerized systems.
Leverage risk management principles to drive risk-based validation testing and decision-making.
Author, review and approve validation master plans, project plans, validation protocols, validation reports, deviations, and change controls in accordance with Lonza's quality management system.
Develop, execute, and review validation protocols (DQ, IQ, OQ, PQ) for new and modified equipment, processes, and systems.
Peer review/approve validation protocols, and summary reports generated by junior and contract personnel; monitor and track validation schedules and progress, escalating any potential delays or issues to management.
Provide technical leadership by representing Engineering Validation on project teams and coordinate activities of Engineering, MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects.
Support internal and external audits by providing documentation and technical explanations of validation activities.

What we are looking for:

Bachelor's degree in Engineering (Computer Science, Information Technology), Life Sciences, a related field or significant related work experience.
Minimum of 5-8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements for validation activities.
Proven experience with validation of the Process Automation Systems, Distributed Control System (DCS), Manufacturing Control System (MCS), Programmable Logic Controllers (PLC), Building Automation System (BAS) and manufacturing equipment/systems is required.
Experience with server administration, NetApp storage technologies, and core network infrastructure fundamentals will be a plus.
Direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing equipment, facilities, utility, automation and computerized systems.
Strong technical writing, verbal communication, interpersonal and problem-solving skills; ability to work independently and as part of a team, organize and manage individuals as well as lead larger scale projects.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Apply Now

Refine Your Search

quality engineer medical device jobs in vacaville, ca

Senior Validation Engineer - CSV (OT)

Project Engineer 2-3

Test Engineer

Power System SCADA and Controls – Specialist / Engineer

Senior Mechanical Engineer, Applications & Automation

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