Senior Project Manager in Elkton, Virginia at Valsource

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

Responsibilities/Requirements

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

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 / ValGenesis / Veeva

On-Site Project Management:

• 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.

Validation Execution:

• 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.

Regulatory Compliance:

• 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.

Other Responsibilities

• 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.

Education

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

Other information & Work Authorization

This is a direct-hire, full-time position with ValSource, 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. ValSource does not currently provide employment visa sponsorship or employment-based immigration benefits for this position, now or in the future.

In accordance with federal law, all hired employees will be required to verify their identity and authorization to work in the United States. ValSource 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.

About ValSource

ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity

ValSource 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.