GMP Validation Lead for Facility Start-Up

GrayMatter Partners; Worcester (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

GrayMatter Partners is seeking an experienced Validation Project Manager to lead critical regulated projects in our life sciences practice. The role focuses on planning, executing, and documenting validation activities for GMP equipment, facilities, and processes.

You will collaborate with engineering, quality, and manufacturing teams to deliver compliant, validated systems and drive risk-based validation strategies across the project lifecycle.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5+ years of engineering experience in life sciences (biopharma, pharma, or medical devices).
• Knowledge of cGMP, FDA, EMA, ICH Q7/Q9/Q10, and 21 CFR Part 11.
• Strong communication across technical and non-technical teams.

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

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

GrayMatter Partners is seeking an experienced Validation Project Manager to lead critical regulated projects in our life sciences practice. The role focuses on planning, executing, and documenting validation activities for GMP equipment, facilities, and processes.

You will collaborate with engineering, quality, and manufacturing teams to deliver compliant, validated systems and drive risk-based validation strategies across the project lifecycle.