Sterility Assurance Advisor

JCW Group; Iowa (LA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Relocation package

Excellent benefits

Job summary

JCW Group is assisting a client in the Des Moines, IA area to hire a Sterility Assurance & Contamination Control Strategy Leader who will provide technical leadership across sterile manufacturing operations onsite.

This is an onsite opportunity with a great relocation package and excellent benefits, ideal for leaders with 12+ years in sterile manufacturing, CCS development, and environmental monitoring who can influence cross‑functional teams.

Qualifications

• 12+ years of experience in sterile manufacturing, aseptic processing, biotechnology, or a related regulated environment.
• Strong experience in sterility assurance and contamination control.
• Developed or implemented Contamination Control Strategies (CCS).
• Experience developing and managing Environmental Monitoring programs.
• Experience with EU GMP Annex 1 and regulatory inspections/audits.
• Experience leading contamination investigations, sterility failures, deviations, and CAPAs.
• Experience working with bioreactors, fermenters, cell culture, or other upstream manufacturing processes.
• Ability to influence cross-functional teams and provide technical leadership.

Skills

Sterility assurance

Contamination control

CCS implementation

Environmental monitoring

EU GMP Annex 1

Regulatory inspections

CAPA leadership

Upstream manufacturing

Cross-functional leadership

Job description

Our client in the Des Moines, IA area is looking to hire a Sterility Assurance & Contamination Control Strategy Leader to provide technical leadership across sterile manufacturing operations. This is an onsite opportunity with a great relocation package and excellent benefits.

You should apply if you:

• Have 12+ years of experience in sterile manufacturing, aseptic processing, biotechnology, or a related regulated environment
• Have strong experience in sterility assurance and contamination control
• Have developed or implemented Contamination Control Strategies (CCS)
• Have experience developing and managing Environmental Monitoring programs
• Have experience with EU GMP Annex 1 and regulatory inspections/audits
• Have experience leading contamination investigations, sterility failures, deviations, and CAPAs
• Have experience working with bioreactors, fermenters, cell culture, or other upstream manufacturing processes
• Have a strong ability to influence cross-functional teams and provide technical leadership