Commissioning and Qualification Lead (Insulin Manufacturing)

Location: IFB project site in Beijing, China, with limited local and international travel

Company

hirify.global is a pharmaceutical organization developing and manufacturing medicines, including insulin and other biologic therapies.

What you will do

• Lead commissioning, qualification, and validation activities for a large-scale insulin manufacturing facility from design through commercial readiness.
• Develop risk-based validation strategies aligned with ICH Q9 and global regulatory expectations.
• Build and manage a CQV team, project governance model, KPIs, reporting, and delivery plans.
• Oversee qualification of facilities, utilities, equipment, processes, and automated manufacturing systems, including IQ/OQ/PQ.
• Lead computer system validation and implement the KNEAT digital validation platform for CQV documentation and workflows.
• Coordinate Engineering, Quality, Operations, Regulatory Affairs, vendors, consultants, and global stakeholders while supporting technology transfer and process validation.

Requirements

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical, Biotechnology, or a related discipline.
• At least 10 years of progressive CQV experience in pharmaceutical or biopharmaceutical manufacturing, including greenfield projects.
• Expertise in risk-based validation, FMEA, HACCP, ICH Q7/Q8/Q9/Q10, FDA 21 CFR Part 11, and EU GMP Annex 11 and 15.
• Extensive experience with KNEAT, computer system validation, GAMP 5, data integrity, and electronic quality systems.
• Strong knowledge of aseptic processing, sterile manufacturing, biologics, insulin production, and validation of HVAC, WFI, clean steam, and compressed air systems.
• Strong written and verbal English communication skills and ability to work at the Beijing project site with limited travel.

Nice to have

• Experience with continuous process verification and lifecycle validation.
• Knowledge of Industry 4.0 and digital transformation in pharmaceutical manufacturing.
• PMP or Six Sigma Green/Black Belt certification.
• Experience with additional digital validation tools and eQMS.
• Previous insulin or biologics manufacturing experience.

Culture & Benefits

• Opportunity to contribute to a strategic project involving life-changing therapies.
• Collaborative and innovative environment with global exposure.
• Professional development and career growth opportunities.
• Competitive compensation and benefits package.
• Commitment to diversity, inclusion, and equal employment opportunities.