Senior Manager, Metrology (GMP)

Location: Waltham, Massachusetts, United States

Salary: $150,000–$200,000 per year

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, services, and manufacturing expertise for developing advanced therapies from design through commercialization.

What you will do

• Lead calibration and testing activities at the facility, supervising associates and contractors.
• Coordinate workloads, reassign resources, and resolve issues involving vendors, contractors, and internal or external clients.
• Review and approve procedures, work orders, reports, and GMP documentation while driving system improvements.
• Define calibration tolerances and ranges with system and equipment owners.
• Develop and revise metrology SOPs and equipment-specific calibration procedures.
• Prepare for and support quality audits, investigate quality issues, and communicate with auditors.

Requirements

• Bachelor’s degree with at least 8 years of related experience, a master’s degree with at least 6 years, or a PhD with at least 4 years.
• Experience calibrating process, laboratory, packaging, and utility systems instrumentation and equipment in a GMP environment.
• Experience reviewing GMP documentation and participating in client, regulatory, and internal audits.
• Experience presenting and defending calibration programs during regulatory audits.
• Ability to read and follow SOPs, P&IDs, and work instructions, with strong written and verbal communication skills.
• Strong Microsoft Excel and Microsoft Office skills; experience with Blue Mountain RAM or another CMMS is preferred.

Culture & Benefits

• Regular employment within the Facilities and Engineering department.
• Responsibilities include training and mentoring staff and developing knowledge-retention programs.
• Work requires extended standing, walking, bending, stretching, and repetitive hand and arm motions.
• Ability to lift 25–50 lbs, climb step ladders, and perform physical tasks while wearing PPE.
• Focus on workplace safety, equipment integrity, traceability, quality, and regulatory compliance.