GMP Manufacturing Ops & CAPA Specialist

Genezen; Lexington (MA); On-site; USD 65,000 - 105,000; Full time

Job summary

Genezen in Lexington, MA seeks a Manufacturing Operations Support Specialist - Commercial to join a focused team handling deviations, CAPAs, and change controls across manufacturing. The role requires independent decision making and strong GMP/Biopharma knowledge.

The incumbent will support equipment, documentation, and process improvement initiatives, liaising with cross-functional groups to ensure manufacturing readiness and compliance in a fast-growing biomanufacturing environment.

Qualifications

• BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience
• Minimum 1-8+ years related industry experience
• Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls
• Experience in biomanufacturing unit operations (USP and/or DSP)
• Experience performing root cause analysis using methods such as Event & Causal Factor Charting, Kepner-Tregoe, and basic Quality tools
• Able to adhere to internal and regulatory (EMA, FDA) policies, processes and procedures
• Ability to apply systems thinking as part of problem-solving
• Demonstrates industrial empathy when working with stakeholders
• Detail oriented and able to self-organize
• Communicate professionally across diverse levels and channels
• Takes initiative to own and resolve issues
• Good technical writing and oral communication skills

Responsibilities

• Practices and promotes safe work habits and adheres to safety procedures
• Identifies and resolves manufacturing issues, improves process operations
• Performs root cause analysis on quality events and leads investigations
• Drives corrective and preventive actions (CAPAs)
• Provides manufacturing support for tech transfers
• Participates in Change Control reviews and prepares impact assessments
• Works with cross-functional teams to drive complex manufacturing improvements
• Supports document revisions and batch records and procedures
• Conducts staff training on floor
• Assists processing technology (chromatography, filtration, digital systems)
• Engages in equipment start-up, commissioning, and validation activities
• Reviews work and provides constructive feedback
• Generates trending and metrics reports
• Maintains GMP compliance in documentation and practices
• Operates with independent judgment with periodic guidance

Skills

Systems thinking

Industrial empathy

Detail oriented

Professional communication

Initiative

Technical writing

Education

Biology/biochemistry/molecular biology degree

Job description

Genezen in Lexington, MA seeks a Manufacturing Operations Support Specialist - Commercial to join a focused team handling deviations, CAPAs, and change controls across manufacturing. The role requires independent decision making and strong GMP/Biopharma knowledge.

The incumbent will support equipment, documentation, and process improvement initiatives, liaising with cross-functional groups to ensure manufacturing readiness and compliance in a fast-growing biomanufacturing environment.