Sterility Assurance Specialist

Randstad
4500.00 - 6000.00
32-40 hours
Bachelor degree

Client

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Requirements

BSc/MSc degree in Microbiology, Pharmacy or a related discipline.
Significant experience in sterility assurance in the pharmaceutical field.
In dept knowledge of GMP, contamination control, aseptic technique, validation and regulatory guidelines.
Strong technical proficiency in cleanroom operations, sterilization technologies and environmental monitoring programs.

What do you get?

Pension entitlement as from day one
Collective WGA / WIA insurance
NBBU / ABU collective labor agreement
25 holidays days
8,33% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance

Duties

Advise on facility layout, cleanroom design, utilities, equipment selection, and process flows to minimize contamination risk and ensure GMP and regulatory compliance.
Oversee aseptic manufacturing of parenteral drug products including lyophilized, solution, and suspension forms.
Lead validation and qualification of critical processes, equipment, cleaning, sterilization, and utilities according to GMP standards.
Implement and maintain cleanroom classifications (ISO/FDA/EU) and enforce stringent gowning and cleanroom behaviour protocols.
Oversee and optimize unidirectional flow, barrier technologies (RABS, isolators), and operations in Grade A/B/C/D environments.
Design, execute, and monitor robust environmental monitoring programs (viable and non-viable).
Manage sterilization systems (autoclaves, SIP, CIP) ensuring compliance and operational effectiveness.
Design, plan and oversee media fill simulations, including failure investigations and corrective actions to ensure process sterility.
Support container closure integrity testing (CCIT) and related sterility assurance activities.
Participate actively in qualification lifecycle stages of cleanrooms (DQ/IQ/OQ/PQ) and review/approve validation protocols for aseptic processes and personnel qualifications.
Develop, deliver, and improve training programs on aseptic technique, gowning, cleanroom behavior, and incident response for manufacturing teams.
Prepare, review, and maintain sterility assurance documentation such as SOPs, protocols, validation reports, and investigation records.
Guide risk assessments and troubleshooting for deviations, facility/process changes, and during production ramp-up and qualification.