GMP Process Engineer (Biotechnology)

Location: St. Paul, Minnesota, United States; onsite work required during standard business hours

Salary: $69,800–$114,800 per year

Company

hirify.global enables research in life sciences and clinical diagnostics by providing tools that support disease treatment and prevention.

What you will do

• Provide technical and engineering support for GMP reagent manufacturing, including troubleshooting process and equipment issues.
• Lead investigations into deviations, non-conformances, contamination events, environmental monitoring excursions, and out-of-trend results.
• Perform root cause analyses and develop or implement CAPAs, change controls, risk assessments, and technical impact evaluations.
• Execute and support process validation, equipment qualification, cleaning validation, media fills, and ongoing process verification.
• Analyze manufacturing data, identify improvement opportunities, and support contamination control, aseptic processing, technology transfers, and process optimization.
• Prepare technical documentation and collaborate with Manufacturing, Quality, Validation, Engineering, Regulatory, and audit teams.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, biology, microbiology, chemical engineering, life sciences, or a related discipline.
• 2–5 years of GMP manufacturing experience in biotechnology, diagnostics, biologics, pharmaceutical, or life sciences industries.
• Broad bioprocessing and manufacturing support knowledge, including fermentation, protein purification, formulation, filling, or aseptic processing.
• Experience with non-conformance and deviation investigations, CAPA, change control ownership, validations, and equipment qualifications.
• Ability to train personnel in aseptic techniques and GMP manufacturing practices.
• Working knowledge of Five Whys, Fishbone Analysis, FMEA, process mapping, and risk assessment tools.
• Strong organizational skills for managing multiple priorities and strong communication skills with stakeholders at different organizational levels.
• Ability to work onsite in a laboratory and production environment, handle chemicals and reagents, and lift materials weighing 5–50 lbs.

Culture & Benefits

• Standard business-hour schedule with occasional variation based on production needs.
• Medical, dental, vision, life, disability, pet, legal, and identity-protection benefits beginning on day one.
• 401(k), employee stock purchase plan, HSA, FSA, dependent care FSA, paid holidays, paid time off, and paid parental leave.
• Mentorship, training and development, tuition reimbursement, and promotional opportunities.
• Employee resource groups, volunteer paid time off, employee events, charity drives, and an empowerment- and innovation-focused culture.

Hiring process

• Applications must be submitted directly by candidates; unsolicited resumes from other sources are not accepted.
• Applicants must already have US work authorization that does not now or in the future require visa sponsorship.