Sr. Engineer, Commissioning, Qualification, and Validation

Location: Norwood, Massachusetts, United States; may telecommute up to 30%.

Salary: $130,800–$209,400 annually; target pay for the primary location is $170,000–$209,400.

Company

hirify.global develops biotechnology and pharmaceutical products, including medicines and vaccines.

What you will do

• Manage commissioning, qualification, and validation activities for a GMP manufacturing facility.
• Establish and maintain the validated status of facilities, utilities, equipment, processes, automation, computer systems, and laboratory instruments.
• Track requalification metrics, report status, and coordinate commitments with key stakeholders.
• Own change controls, deviations, CAPAs, investigations, and continuous improvement initiatives related to validation.
• Provide validation expertise for controlled-temperature units, analytical instruments, chromatography, ultrafiltration, mixers, tanks, vessels, bioreactors, and fermenters.
• Lead cross-functional validation projects, review contractor deliverables, manage contractor priorities, and deliver initiatives on schedule.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences or a related life science field.
• At least 5 years of progressive post-baccalaureate experience in a GMP manufacturing environment as a Senior Validation Engineer, Validation Engineer, CQV Engineer, or in a related role.
• Experience writing Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports.
• Experience authoring validation-related change controls, deviations, and investigations.
• Experience executing validation activities, improving periodic review and requalification programs, and developing testing requirements from manufacturing equipment knowledge.
• Must work from the Norwood, Massachusetts location, with telecommuting permitted up to 30%.

Culture & Benefits

• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities, location-specific perks, and potential bonus, incentive compensation, or equity awards.