Senior Project Manager

Position Overview

Val Source is looking to hire a Commissioning, Qualification, and Validation (CQV) Senior Project Manager in our Southeast Region (Elkton, Virginia). This full‑time employee will support commissioning, qualification, validation, and process engineering projects with clients throughout the Southeast region.

As the Project Manager (PM), you will report to the client's Delivery Manager and CQV Lead, manage and mentor the CQV team on large‑scale projects, and serve as the primary point of contact. You will support the client's Engineering Department through early design phases, including concept design and basic design deliverables.

• HVAC / Cleanroom Qualification
• GMP Utilities (WFI, Clean Steam, Gases)
• Process Equipment
• Autoclaves/Sterilizers
• Environmental Monitoring
• Computer System Validation
• DeltaV / BAS / EMS / BMS
• ASTM 2500 Commissioning
• ISPE C&Q Methodology
• Risk Assessments/URS/RTM
• Protocol Generation
• Field Execution
• Kneat / Val Genesis / Veeva

• Interface with clients, lead teams of validation professionals, and provide subject‑matter expertise in the validation of a variety of utility, facility, and process equipment.
• Develop and maintain project schedules, ensuring timely completion of all validation activities.
• Coordinate on‑site resources, including internal teams, contractors, and client personnel.
• Manage overall project execution and deliverables related to commissioning, qualification and validation of pharmaceutical or biotech manufacturing equipment and processes.
• Oversee activities related to the start‑up, commissioning, qualification, and validation of GMP manufacturing facility systems and equipment.

• Field execute and oversee on‑site validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Troubleshoot and resolve issues that arise during validation activities, providing technical expertise and guidance.
• Ensure all validation work complies with regulatory guidelines, client requirements, and company SOPs.
• Conduct field verifications and system walkdowns to confirm systems meet design and client specifications.

• Ensure compliance with all relevant regulatory standards, including FDA, GMP, and ICH guidelines, during on‑site validation.
• Prepare for and support client regulatory inspections and audits as needed.
• Maintain up‑to‑date knowledge of industry regulations and best practices.

• Develop project scope statements, estimates, and proposals.

• Must be able to delegate, keep the team accountable, serve as primary point of contact, support tracking, and manage the budget.
• Minimum 15 years of FDA‑regulated / GMP experience.
• Experience with Drug Substance/API facilities.

Senior‑level Project Manager with a Bachelor of Science degree in Engineering, Biology, Chemistry, Microbiology, Computer Science, or a related technical discipline.

Candidates must be legally authorized to work in the United States on a full‑time basis at the time of application and throughout employment. Val Source does not provide immigration sponsorship.

Full benefits package including medical, dental, vision, short‑ and long‑term disability, 401(k), paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, and discretionary bonus.

Val Source provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.