Validation Project Manager

Join GrayMatter Partners, a fast-growing life sciences consulting company making an impact in biotech and pharma innovation. We partner with leading organizations to navigate regulatory requirements, ensure validated systems, and maintain the highest levels of quality throughout the product lifecycle. We’re looking for passionate professionals to grow with us!

We are seeking an experienced Validation Project Manager to join our team. The ideal candidate will bring 5+ years of hands-on expertise in regulated life sciences environments.

Key Responsibilities:

· Manage validation projects for a facility start up.

· Execute commissioning, qualification, and validation activities for GMP equipment, utilities, facilities, and processes

· Develop and execute validation lifecycle documentation

· Support FAT, SAT, commissioning, and startup activities

· Coordinate with engineering, quality, manufacturing, automation, and project teams to ensure successful project delivery

· Review technical documentation including P&IDs, specifications, SOPs, and design documents

· Support continuous improvement initiatives and risk-based validation strategies

Qualifications

· Bachelor’s degree in Engineering or related field (advanced degree preferred).

· 5+ years of experience in engineering within the life sciences industry (biopharma, pharma, or medical devices).

· Strong knowledge of cGMP, FDA, EMA, ICH Q7/Q9/Q10, and 21 CFR Part 11.

· Strong interpersonal skills with the ability to communicate effectively across technical and non-technical teams.

Perks and Benefits

· Medical, Dental, and Vision Insurance

· 401(k) Program

· PTO and Sick Time

· Unique Culture and Values

Pay: $80,000.00 - $110,000.00 per year

Application Question(s):

• Will you now or in the future require work visa sponsorship?

Work Location: In person