Validation Lead Engineer – Life Sciences CQV

PerkinElmer; California (MO); Hybrid; USD 85,000 - 100,000; Full time

Job summary

PerkinElmer in South San Francisco, CA seeks a Validation Lead Engineer for Project Farma. This full-time role involves leading high-impact validation tasks, CQV protocol development, and coordinating with cross-functional teams to deliver high-quality life-sciences projects.

You will mentor junior engineers, ensure FDA/GMP compliance, and travel domestically as required. The position supports project controls, dashboards, and client relations to drive successful outcomes.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or related discipline.
• Minimum 4–7 years in consulting and/or engineering services.
• Full-time on-site client presence and willingness to travel up to 100%.

Responsibilities

• Execute specific technical tasks within a project, ensuring high-quality deliverables.
• Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead’s guidance.
• Report technical issues to the Site Lead and support resolution efforts.
• Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards.
• Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
• Identify and close individual knowledge gaps with support from other team members or leads as needed.
• Execute system and process validation protocols by using GxP best practices.
• Support necessary billables as forecasted by site dashboards on billable targets per month.
• Communicate updates internally in a timely manner and relay in-field project decisions to highlight long-range, down-stream project and team impacts.
• Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
• Perform due diligence on system and subject domains to generate high-quality project deliverables.
• Proactively identify and expedite escalation of roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks.
• General understanding of Earned Value Analysis (EVA) and project management tools May be requested to assist with Project Controls and Scheduling to include; Budget estimates, detailed project schedules and milestones, feasibility estimates, risks, forecasts and scenario analysis and project cost reports and analysis.
• Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, Engineering and Project Controls.
• Maintain internal site tools such as site dashboards, deliverable trackers, etc.
• Continually develop technical aptitude of Project Farma’s core services within the life science space including but not limited to: Capital Project Management, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial.
• Analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making.

Education

Bachelor’s Degree in Life Science, Engineering, or related discipline

Job description

PerkinElmer in South San Francisco, CA seeks a Validation Lead Engineer for Project Farma. This full-time role involves leading high-impact validation tasks, CQV protocol development, and coordinating with cross-functional teams to deliver high-quality life-sciences projects.

You will mentor junior engineers, ensure FDA/GMP compliance, and travel domestically as required. The position supports project controls, dashboards, and client relations to drive successful outcomes.