Sr. Validation Engineer (cGMP) - Project Farma

PerkinElmer • Raleigh, NC

2d • Onsite

About The Position

This is a full-time salaried position with Project 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.

Requirements

• 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.
• 1-5 years in consulting and/or engineering services
• Willingness to travel as required for client project assignments.
• Applicants must be authorized to work in the United States on a full-time basis.
• We cannot employ anyone with an invalid driver's license.

Nice To Haves

• Full-time on-site client presence
• Willingness to travel up to 100% or as required.
• 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.

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

Benefits

• Full-time salaried position

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level