Validation - Lead Engineer - Project Farma

PerkinElmer • South San Francisco, CA

2d • $85,000 - $100,000 • Onsite

About The Position

This is a full-time salaried position with Project Farma, a PerkinElmer company. 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 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 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.

Requirements

• Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.
• Minimum 4-7 years in consulting and/or engineering services.
• Full-time on-site client presence.
• Willingness to travel up to 100% or as required for client project assignments.
• Applicants must be authorized to work in the United States on a full-time basis.
• We will not sponsor applicants for current or future work visas for this position.
• This position may require significant travel to support project and business needs.
• We cannot employ anyone with an invalid driver's license.

Nice To Haves

• Demonstrated depth in their technical discipline and a growing record of leading complex workstreams.
• Strong subject matter expertise to solve high impact technical and operational challenges.
• Ability to support technical decision making.
• Contributes to the evolution of standards, methods, or best practices within their area.
• Works with a high degree of independence.
• Mentors junior and peer engineers.
• Partners closely with project and people leaders—while remaining focused on technical delivery rather than formal people management.
• General understanding of Earned Value Analysis (EVA) and project management tools.
• Experience with CQV tasks, such as protocol development or equipment testing.
• Experience authoring technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc.
• Experience executing system and process validation protocols by using GxP best practices.
• Experience providing hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
• Experience performing due diligence on system and subject domains to generate high-quality project deliverables.
• Ability to proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks.
• Experience creating alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, Engineering and Project Controls.
• Experience maintaining internal site tools such as site dashboards, deliverable trackers, etc.
• Experience continually developing 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.
• Ability to analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making.
• Ability to share technical knowledge with peers to support project delivery.
• Ability to mentor less experienced team members.
• Ability to participate in Project Farma internal qualification training program.
• Ability to support the execution of site strategy under the direction of the Site Lead, contributing to specific project tasks that align with Project Farma’s services.
• Ability to perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols.
• Ability to identify and report client needs or project challenges to the Site Lead for further action.
• Ability to maintain professional relationships with project team members and client POCs at the operational level (e.g., technicians, engineers) to facilitate task completion.
• Ability to provide input on task-level resource needs to the Site Lead to support project delivery.
• Ability to report workload or skill gaps within assigned tasks.
• Ability to assist in maintaining project schedules by communicating resource constraints.
• Ability to contribute to project-level success by delivering high-quality work that supports business growth opportunities.
• Ability to build meaningful internal and external relationships.
• Ability to present Project Farma as a service to clients as needed.
• Ability to communicate with clients in a professional manner.
• Ability to ensure any client feedback or opportunities identified are being escalated properly.
• Ability to provide data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards or expansion discussions.
• Ability to participate in project tasks that support extensions or proposals, such as preparing deliverables for clients.
• Ability to identify opportunities for cross-selling and up-selling of additional Project Farma services outside of the Validation dicscipline.
• Ability to maintain 100% individual billability by completing assigned project tasks.
• Ability to escalate any roadblocks on achieving billable targets to the site lead.

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 escalate 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.
• Focus on professional development and support team collaboration under the Site Leads guidance.
• Share technical knowledge with peers to support project delivery. Mentor less experienced team members.
• Participate in Project Farma internal qualification training program.
• Support the execution of site strategy under the direction of the Site Lead, contributing to specific project tasks that align with Project Farma’s services.
• Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols.
• Identify and reports client needs or project challenges to the Site Lead for further action.
• Maintain professional relationships with project team members and client POCs at the operational level (e.g., technicians, engineers) to facilitate task completion.
• Provide input on task-level resource needs to the Site Lead to support project delivery.
• Report workload or skill gaps within assigned tasks.
• Assist in maintaining project schedules by communicating resource constraints.
• Contribute to project-level success by delivering high-quality work that supports business growth opportunities.
• Build meaningful internal and external relationships.
• Present Project Farma as a service to clients as needed.
• Communicate with clients in a professional manner.
• Ensure any client feedback or opportunities identified are being escalated properly.
• Provides data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards or expansion discussions.
• Participate in project tasks that support extensions or proposals, such as preparing deliverables for clients.
• Identify opportunities for cross-selling and up-selling of additional Project Farma services outside of the Validation dicscipline.
• Maintain 100% individual billability by completing assigned project tasks.
• Escalate any roadblocks on achieving billable targets to the site lead.

Benefits

• PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior