Sterility Assurance Specialist

Adryan; Leiden; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in the Netherlands is seeking a Sterility Assurance Specialist for a 1-year contract with possible extension. The role focuses on aseptic operations, contamination control activities, and technical documentation. Ideal candidates will possess an MSc in Microbiology and at least 2 years of relevant experience. Responsibilities include authoring risk assessments, providing microbiological oversight during media fills, and leading efforts on Grade A/B excursions. Competitive compensation and professional growth opportunities available.

Qualifications

• Minimum 2 years of hands-on QC Microbiology experience.
• Strong practical knowledge of EU GMP Annex 1 (2022); PDA guidance is a plus.

Responsibilities

• Author and own contamination control documentation and risk assessments.
• Perform hands-on risk assessments related to material and personnel flows.
• Support microbiological controls for incoming raw materials.
• Contribute to CCIT strategy definition.
• Act as lead for Grade A/B EM excursions, including containment, RCA, and CAPAs.

Skills

Microbiology expertise

Contamination control

Aseptic technique

Technical documentation

Education

MSc in Microbiology

Job description

Sterility Assurance Specialist (1-Year Contract, Possible Extension)

Duration: 1 year with possible extension

Role Overview

We are looking for a hands‑on Sterility Assurance Specialist to support aseptic operations and contamination control activities. This is a technical oriented role, focused on execution and ownership.

Core Responsibilities

• Author and own contamination control documentation and risk assessments.
• Perform hands‑on risk assessments related to:
• Material and personnel flows
• PUPSIT design and gowning in aseptic areas
• Support microbiological controls for incoming raw materials.
• Contribute to CCIT strategy definition.
• Support steam sterilization and sanitization strategies (SIP, autoclaves).
• Act as lead for Grade A/B EM excursions, including containment, RCA, and CAPAs.

Aseptic Operations

• Personally deliver aseptic behaviour and gowning training.
• Participate in and provide microbiological oversight during APS / media fills.

Key Requirements

• MSc in Microbiology (mandatory).
• Minimum 2 years of hands‑on QC Microbiology experience.
• Preferably 2+ years in a Sterility Assurance role within pharmaceutical manufacturing.
• Strong, practical knowledge of EU GMP Annex 1 (2022); PDA guidance is a plus.