Senior Project Manager - Validation

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

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

Requirements and Technical Specialties are expected to include but are not limited to the following:

• HVAC / Cleanroom Qualification
• GMP Utilities (WFI, Clean Steam, Gases)
• Process Equipment
• Computer System Validation
• ISPE C&Q Methodology
• Protocol Generation
• Field Execution

• 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.
• Project Manager is responsible for the overall project execution and project deliverables related to Commissioning, Qualification and Validation of pharmaceutical or biotech manufacturing equipment and processes in the manufacturing field.
• Also responsible for activities related to the start‑up, commissioning, qualification, validation of Pharmaceutical and Biotech 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 is performed in accordance with regulatory guidelines, client requirements, and company SOPs.
• 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.
• Stay current with industry regulations and best practices to ensure compliance.

• The Project Manager will be responsible for developing project scope statements, estimates and proposals.

• Must be able to delegate, keep team accountable, serve as primary point of contact, support tracking, manage budget.
• Must have 15 years (minimum) of FDA‑regulated / GMP experience.
• Must have 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.

This is a direct‑hire, full‑time position with Val Source, Inc.
We are not accepting submissions from staffing agencies, recruiting firms, independent contractors, or other third‑party vendors. Unsolicited resumes submitted by agencies will not be considered and will not create any obligation for consideration or compensation.

Candidates must be legally authorized to work in the United States on a full‑time basis at the time of application and throughout their employment. Val Source does not currently provide employment visa sponsorship or employment‑based immigration benefits for this position.

In accordance with federal law, all hired employees will be required to verify their identity and authorization to work in the United States. Val Source participates in E‑Verify and will provide information from the Form I‑9 to the U.S. Department of Homeland Security and the Social Security Administration, as applicable, to confirm employment eligibility.

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.