Senior Validation Engineer & Lead - Travel-Heavy

PerkinElmer

Indianapolis (IN)

On-site

USD 80,000 - 115,000

Full time

4 days ago
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Benefits offered by this job

Full-time on-site client presence

Job summary

Project Farma, a PerkinElmer company in the United States, seeks a Validation Lead Engineer willing to travel domestically. This role is a high-impact individual contributor focused on CQV, system validation, and technical delivery across client projects in the life sciences space.

The candidate will mentor peers, partner with Site Leads, and support project controls, schedules, and risk analysis while ensuring compliance with FDA/GMP standards.

Qualifications

  • Bachelor’s degree in Life Science, Engineering, or related discipline.
  • 4–7 years of experience in consulting and/or engineering services.
  • Willingness to travel as required for client project assignments.

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 elevate 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

Skills

Willingness to travel

Education

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

Job description

Project Farma, a PerkinElmer company in the United States, seeks a Validation Lead Engineer willing to travel domestically. This role is a high-impact individual contributor focused on CQV, system validation, and technical delivery across client projects in the life sciences space.

The candidate will mentor peers, partner with Site Leads, and support project controls, schedules, and risk analysis while ensuring compliance with FDA/GMP standards.

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