Validation Engineer​/Lead; cGMP; Project Farma

Project Farma will consider candidates' ranging from 1-7+ years' relevant experience. The successful candidate will
reside within 50 miles of Raleigh, NC 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-changingtherapies.Weaccomplishthisthrough the successful 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 being
curious
,
personable
, and
unselfish
, whilemaintaininga strong commitment to a
Patient Focused and People First mindset
.

• 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 leadsas needed.
• Execute system and process validation protocols by using
  
  GxPbest 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 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-edge equipment 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- solving skills 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.

• 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) tofacilitatetask 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…