Validation - Engineer III/Lead - Project Farma

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

Role Summary

This is afull-time salaried position withProject Farma,a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and bewilling to travel domesticallyto meet client project requests.

Project Farma’s purpose is toimprove 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 beingcurious,personable, andunselfish, while maintaining a strong commitment to aPatient Focused and People First mindset.

TheValidationLeadEngineeris an advanced individual contributor withdemonstrateddepth in their technical discipline and a growing record of leading complex workstreams. This role applies strongsubjectmatterexpertiseto solvehighimpacttechnical and operational challenges, supports technicaldecisionmaking, and contributes to the evolution of standards, methods, or best practices within their area. TheLeadEngineer works with a high degree of independence, mentors junior and peer engineers, and partners closely with project and people leaders—whileremainingfocused 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.
  • Identifyand close individual knowledge gaps with support from other team members or leadsas needed.
  • Execute system and process validation protocols by usingGxPbest practices.
  • Support necessary billables as forecasted by site dashboards on billable targets per month.
  • Communicate updates internallyin a timely mannerand 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 ofcutting-edgeequipment and manufacturing processes.
  • Perform due diligence on system and subject domains to generate high-quality project deliverables.
  • Proactivelyidentifyand elevate roadblocks andutilizecritical thinking skills and knowledge of problem- solvingskills toidentifycreative solutions to those problems and roadblocks.
  • General understanding of Earned Value Analysis (EVA) andprojectmanagement tools
  • May be requested toassistwith 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,GxPAutomated Systems, and Quality Control including clinical and commercial.
  • Analyze complex project data and then deliver clear,articulateand 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.Mentor less experienced team members.
  • Participate in Project Farma internal qualification training program.
Site Strategy
  • 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 strategicobjectives, such as preparing and executing CQV Protocols
  • Identifyand 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) tofacilitatetask completion
Resource Management
  • Provide input on task-level resource needs to the Site Lead to support project delivery.
  • Report workload or skill gaps within assigned tasks.
  • Assistinmaintainingproject schedules by communicating resource constraints.
Business Growth & Development
  • 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.
  • Ensureany client feedback or opportunitiesidentifiedare 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.
  • Identifyopportunities for cross-selling and up-selling ofadditionalProject Farma services outside of the Validationdicscipline.
Operational Performance & Billability
  • Maintain 100% individual billability by completing assigned project tasks.
  • Escalate any roadblocks on achieving billable targets to thesitelead.
Attributes for Success
  • Technical Delivery: Applies advanced technical knowledge and professionalexpertise
  • Innovation & Continuous Improvement: Seeks better ways, adapts to change and championsnew ideas.
  • Customer Focus & Professionalism:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations
  • Integrity & Humility:Demonstratesself-awareness and puts PF mission above ego
  • Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
  • Project Execution: Delivers reliably, managesprioritiesand drives forhigh qualityoutcomes
  • Growth Mindset: Shows openness tonew ideas,feedbackand change
Experience Required
  • 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/OpExproject management and/or comparable military experience.
  • Years of Experience: 4-7 years in consulting and/or engineering services
  • Willingness to travel asrequiredfor client project assignments.
Other Preferred
  • Full-time on-site client presence
  • Willingness to travel up to 100% or asrequired.

Project Farmais 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.

Applicants mustbe authorized towork 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.

The annualcompensation range for this full-time position is $80,000 to $115,000. The final base pay offered to the successful candidate will bedeterminedby factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

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