Validation - Engineer III / Lead Engineer - Project Farma

PerkinElmer; California; On-site; USD 90,000 - 140,000; Full time

Job summary

PerkinElmer seeks an experienced Validation - Engineer III / Lead Engineer for Project Farma, to deliver high-quality technical validation work and lead complex tasks across multiple markets in the US. The role requires deep subject-matter expertise, mentoring junior engineers, and collaboration with Project Farma leadership.

The successful candidate will perform CQV activities, develop and review validation protocols, support scheduling and cost tracking, and ensure compliance with FDA/GMP

Responsibilities

• Technical Delivery
• 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 escape 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
• Talent Development
• Focus on professional development and support team collaboration under the Site Leads guidance.
• Share technical knowledge with peers to support project delivery. Men

Job description

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Validation - Engineer III / Lead Engineer - Project Farma

Location(s)

Customer Site - CA, Customer Site - CO, Customer Site - TX, Houston, TX, Los Angeles, CA, Pasadena, CA, Portland, OR, San Diego, CA, South San Francisco, CA

Job Description

The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically to meet client project requests.

Project Farma's purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

All team members are expected to embody Project Farma's values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset.

The Validation Engineer III / Lead Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject-matter expertise to solve high-impact technical and operational challenges, supports technical decision-making, and contributes to the evolution of standards, methods, or best practices within their area. The Validation Engineer III / Lead Engineer works with a high degree of independence, mentors junior and peer engineers, and partners closely with project and people leaders-while remaining focused on technical delivery rather than formal people management.

Key Responsibilities

• Technical Delivery
• 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 escape 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
• Talent Development
• Focus on professional development and support team collaboration under the Site Leads guidance.
• Share technical knowledge with peers to support project delivery. Men