Validation - Engineer III / Lead Engineer - Project Farma

PerkinElmer•San Diego, CA
•$71,000 - $106,000•Onsite

About The Position

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.

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.
  • Years of Experience: 2-7 years in consulting and/or engineering services
  • Willingness to travel as required for client project assignments.
  • Applicants must be authorized to work in the United States on a full-time basis.
  • We cannot employ anyone with an invalid driver's license.

Nice To Haves

  • Full-time on-site client presence
  • Willingness to travel up to 100% or as required.

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

  • The annual compensation range for this full-time position is $(71,000) to $(106,000).
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