Sterility Assurance Expert (Aseptic)

Recipharm; Stockholms kommun; On-site; SEK 1,375,000 - 1,473,000; Full time

Job summary

Recipharm Sweden seeks a Sterility Assurance Manager to lead the site Sterility Assurance Program, ensuring GMP compliance, product quality, and patient safety across aseptic operations, contamination control, and sterilization validation.

You will partner with Quality, Production, CQV, Project Management and clients, provide hands-on coaching, review APS protocols, manage deviations and CAPAs, and drive continuous improvement in sterile manufacturing.

Qualifications

• 8-10 years of experience in pharmaceutical/biotech/CDMO environments.
• Proven experience in Sterility Assurance, Aseptic Manufacturing, and contamination control.
• Experience leading investigations, CAPAs, change controls, and risk assessments.

Responsibilities

• Lead and oversee the site's Sterility Assurance Program, ensuring GMP compliance and internal standards.
• Coordinate Aseptic Process Simulations (Media Fills) and smoke studies with cross-functional teams.
• Review APS protocols/reports to maintain validation and compliance; approve SOPs and risk assessments.
• Mentor manufacturing personnel on aseptic practices and GMP compliance; maintain independence from production.

Skills

Sterility Assurance

Aseptic Processing

Quality Systems

cGMP knowledge

Regulatory Compliance

Education

Master's degree in a relevant discipline

Tools

Microsoft Office

Job description

Recipharm Sweden seeks a Sterility Assurance Manager to lead the site Sterility Assurance Program, ensuring GMP compliance, product quality, and patient safety across aseptic operations, contamination control, and sterilization validation.

You will partner with Quality, Production, CQV, Project Management and clients, provide hands-on coaching, review APS protocols, manage deviations and CAPAs, and drive continuous improvement in sterile manufacturing.