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Validation Engineer III – Lead Engineer
PerkinElmer. Execute technical tasks and deliverables within life sciences projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CQV activities, system and process validation, and compliance with FDA/GMP requirements. Proficient in project management, technical documentation, and mentoring within life sciences projects.
Highest-signal resume keywords
CQV ActivitiesSystem And Process ValidationGxP Best PracticesSOP AuthoringProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Protocol DevelopmentEquipment TestingTechnical Issue ResolutionData AnalysisCost AnalysisRisk ManagementQuality ControlTechnical DocumentationProject SchedulingEarned Value Analysis
Soft Skills
MentoringCommunicationProblem-SolvingCollaborationCreative Solutions
Tools & Technologies
Project Management ToolsInternal DashboardsDeliverable Trackers
Industry Keywords
Life SciencesFDA RequirementsGMP ComplianceCapital Project ManagementPharma cGMP Facility Start-Up
About the role
Key responsibilities & impact- Execute technical tasks and deliverables within life sciences projects
- Perform CQV activities including protocol development and equipment testing under Site Lead guidance
- Report technical issues and support resolution efforts
- Ensure work meets client specifications, FDA/GMP requirements, and industry standards
- Author SOPs, requirements specifications, testing protocols, and summary reports
- Execute system and process validation protocols using GxP best practices
- Provide hands-on support and troubleshooting for equipment and manufacturing processes
- Perform due diligence on systems and subject domains
- Identify and escalate roadblocks and develop creative solutions
- Support project controls and scheduling, including estimates, schedules, risks, forecasts, and cost analysis
- Coordinate with client Validation, Manufacturing, Quality, Supply Chain, Engineering, and Project Controls departments
- Maintain site dashboards, deliverable trackers, and other internal tools
- Develop technical aptitude across capital project management, tech transfers, validation, quality, regulatory and compliance, GxP automated systems, and quality control
- Analyze project data and provide concise insights for decision-making
- Share technical knowledge and mentor less experienced team members
- Participate in Project Farma’s internal qualification training program
- Support site strategy and execute assigned CQV protocols
- Maintain relationships with project teams and client points of contact
- Provide resource-management input and communicate workload or skill gaps
- Contribute to project success, client relationships, proposals, extensions, cross-selling, and up-selling
- Maintain 100% individual billability and escalate barriers to billable targets
Requirements
What you’ll need- Bachelor’s Degree in Life Science, Engineering, or related discipline, or equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience
- 2–7 years in consulting and/or engineering services
- Willingness to travel as required for client project assignments
- Full-time on-site client presence
- Willingness to travel up to 100% or as required
- Must be authorized to work in the United States on a full-time basis
- PerkinElmer will not sponsor current or future work visas
- Must have a valid driver's license
- Strong knowledge of CQV, system and process validation, GxP best practices, FDA and GMP requirements
- Ability to author SOPs, requirements specifications, testing protocols, and summary reports
- General understanding of Earned Value Analysis and project management tools
- Ability to support project controls and scheduling, including budgets, schedules, milestones, risks, forecasts, scenario analysis, and cost reports
- Ability to analyze complex project data and communicate findings clearly
- Ability to mentor junior and peer engineers
- Ability to maintain 100% individual billability
Benefits
Comp & perks- Equal opportunity employer and commitment to a culturally diverse workforce
- Significant domestic travel opportunities