Sterility Assurance Specialist

Sterility Assurance Specialist

Planet Pharma

Leiden, Netherlands

Unleash your expertise in sterile manufacturing and become a key player in ensuring the highest standards of pharmaceutical microbiology. Based in Leiden, this pivotal role offers the opportunity to work within a dynamic, international team dedicated to advancing sterile product quality and compliance. Join us to lead contamination control strategies, drive microbiological excellence, and support groundbreaking aseptic processes with real impact.

What You’ll Bring:

• MSc in Microbiology or a related field;
• Minimum of 2 years’ hands-on experience in QC Microbiology within pharmaceutical manufacturing;
• At least 2 additional years specializing in Sterility Assurance in sterile production environments (injectables);
• Deep knowledge of EU GMP Annex 1 (2022) and preferably PDA guidelines;
• Proven track record in writing and owning contamination control documentation;
• Extensive experience with contamination control strategies and risk assessments—including environmental monitoring, material and personnel flows, and gowning in aseptic areas;
• Practical microbiological control expertise, including raw materials testing;
• Skilled in defining CCIT strategies and managing sterilization processes (SIP, autoclaves);
• Demonstrated leadership in managing environmental excursions, with a focus on containment, root cause analysis, and CAPA development;
• Ability to independently draft technical and risk assessment documentation;
• Proven experience delivering aseptic gowning and microbiological training;
• Exposure to media fill procedures and process validation.

Nice to Have:

• Hands-on familiarity with PUPSIT design and implementation;
• Experience with steam sterilization and sanitization strategies;
• Additional certifications or training in aseptic techniques or contamination control.

Preferred Education & Experience:

• Bachelor's or Master's degree in Microbiology or Pharmaceutical sciences;
• Strong practical experience in sterile pharmaceutical production, especially injectables;
• Prior involvement in risk assessments, containment strategies, and environmental monitoring.

Other Requirements:

• Location: Fully on-site in Leiden, with potential for occasional remote work;
• Language: English (Dutch not required);
• Ability to work within an international team with diverse backgrounds;
• Willingness to participate in face-to-face interviews, including technical assessments and stakeholder discussions;
• This is a long-term opportunity, with a contract until December 2026, with possibility of extension or permanency.