Validation Engineer / Lead (cGMP) - Project Farma

PerkinElmer; Raleigh (NC); On-site; USD 68,000 - 121,000; Full time

Job summary

Project Farma, part of PerkinElmer, is seeking candidates who will reside within 50 miles of Raleigh, NC and be willing to travel domestically to meet client project requests. The role focuses on technical delivery across CQV, regulatory compliance, and project execution in life sciences projects.

The team collaborates to deliver high-quality project outcomes, develop professional skills, and uphold values of curiosity, personable, and patient-focused mindset.

Qualifications

• 1-7 years in consulting and/or engineering services.
• Willingness to travel domestically for client work.
• Residence within 50 miles of Raleigh, NC.

Responsibilities

• Execute specific technical tasks within a project, ensuring high-quality deliverables.
• Perform CQV tasks under guidance of Site Lead.
• Report technical issues and support resolution efforts.
• Ensure tasks meet regulatory requirements (FDA, GMP) and standards.
• Author technical documents (SOPs, specs, protocols, reports).
• Identify knowledge gaps and escalate as needed.
• Execute validation protocols using GxP best practices.
• Support billables as forecasted by site dashboards.

Skills

CQV tasks

Regulatory compliance

GxP knowledge

Project management

Communication

Education

Bachelor’s Degree in Life Science

Job description

Project Farma will consider candidates' ranging from 1-7+ years' relevant experience. The successful candidate willresidewithin 50 miles of Raleigh, NC and bewilling to travel domesticallyto meet client project requests.

Project Farma’s purpose is toimprove patient lives by acceleratingthe delivery of life-changingtherapies.Weaccomplishthisthrough thesuccessful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) teammemberscollaboratewith cross-functional teams to build trusted client relationships, deliveran exceptional customer experience, andcontributeto business growth byidentifyingopportunities 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, whilemaintaininga strong commitment to aPatient Focused and People First mindset.

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.
• Report workload or skill gaps within assigned tasks.
• 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 escalation 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.

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 inProject 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

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.

Operational Performance & Billability

• Maintain 100% individual billability by completing assigned project tasks.
• Escalate any roadblocks on achieving billable targets to the Site Lead.

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: 1-7 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 $68,000 - $121,000. 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.