Our client, a multinational biopharma company, is seeking an Aseptic Operations Specialist to join their team on a 12-month contract.

Responsibilities:

Act as the site expert for aseptic manufacturing.
Help design and set up aseptic manufacturing processes and batch records.
Ensure procedures meet all safety, environmental, GMP, and aseptic regulatory requirements.
Use risk-management tools (pFMEA, What-If, HAZOP) to drive sterility assurance.
Work daily with Aseptic, Quality, and Engineering teams to support safe and timely batch completion.
Promote a strong, high-performance aseptic culture — encouraging open communication and “speak-up” behavior.
Observe aseptic behavior on the floor and give constructive feedback to operators, especially during critical tasks (e.g., set-ups, cleaning, sanitization, EM handling).
Lead and support investigations into sterility, media fill, environmental monitoring, and process issues; help identify root causes and define CAPAs.
Own the tracking, trending, and analysis of Environmental Monitoring (EM) data and drive corrective actions.
Implement new regulations and best practices into site procedures.
Support design and qualification of cleanrooms, equipment, and utilities.
Contribute to the Contamination Control Strategy, APS strategy, and Long-Range Planning for aseptic operations.
Support regulatory inspections as an aseptic/sterility assurance SME.
Train operations personnel in aseptic technique and aseptic processing.
Participate in routine leadership floor walks (GEMBAs).

Requirements:

A degree in Science, Engineering, or Quality.
5+ years of GMP experience, including at least 3 years directly supporting aseptic manufacturing (required).
Strong knowledge of EU GMP Annex 1, FDA 21 CFR Part 210/211/610, and aseptic processing guidance.
Expertise in aseptic risk-management tools (e.g., contamination control strategy, pFMEA, HAZOP).
Experience analysing environmental monitoring data and acting as a microbial SME.
Background in sterility-related investigations (media fill, EM excursions, EMPQ, CAPA).

For a confidential discussion about the role and the organisation, please contact Emma Barry today.

091 70671

Aseptic Operations Specialist