Job TitleSr. Validation Engineer (cGMP) - Project Farma
Location(s)Customer Site - AL, Raleigh, NC
Job DescriptionThis is a
full-time salaried position withProject Farma, a PerkinElmer company. The successful candidate will
reside within 50 miles of Raleigh, NC - Greenville, NC - or Huntsville, AL and be
willing to travel domestically to meet client project requests.
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.
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.
- 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.
- Report workload or skill gaps within assigned tasks.
- 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.
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 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
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.
- 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.
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 professional expertise
- Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
- Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
- Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego
- Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
- Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
- Growth Mindset: Shows openness to new ideas, feedback and 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/OpEx project management and/or comparable military experience.
- Years of Experience: 1-5 years in consulting and/or engineering services
- Willingness to travel as required for client project assignments.
Other Preferred - Full-time on-site client presence
- Willingness to travel up to 100% or as required.
Applicants must be authorized to work 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.
