Operations Aseptic Specialist
As the site's Aseptic Manufacturing SME, this role ensures all aseptic processes, procedures and behaviours align with regulatory requirements and network best practices.
It supports manufacturing operations, drives sterility assurance, and leads continuous improvement across the aseptic value stream.
Responsibilities
Acts as a site subject matter expert for Aseptic Manufacturing, providing essential input into manufacturing process design and batch record development.
Ensures Operations procedures comply with Safety, Environmental, GMP and Aseptic regulatory requirements while driving the correct use of risk-management tools such as pFMEA, What-If and HAZOP.
Partners with Quality, Engineering, Aseptic MQA and Aseptic mentors to support production shifts and ensure safe, compliant and timely batch execution.
Observes aseptic technique and behaviours, giving real-time feedback during critical activities including cleaning, sanitisation, set-up, interventions and EM plate handling.
Leads and supports investigations related to sterility, media fills, EM excursions and EMPQ, contributing to root cause determination and CAPA development.
Owns EM data analysis, trending and the EM visualisation tool while developing action plans and contributing to EM procedures.
Drives continuous improvement through the interpretation of new regulations, implementation of best practices, support of the Site Contamination Control Strategy, APS strategy and long-range planning.
Provides input into cleanroom, equipment and utility design, qualification and requalification activities, as well as preventative maintenance and real-time monitoring strategies.
Supports regulatory audits as the Aseptic/Sterility Assurance SME, delivers aseptic training to Operations personnel and participates in routine manufacturing and testing GEMBAs.
Requirements
Third-level degree in Science, Quality or Engineering.
Minimum 5 years' experience in a GMP environment including at least 3 years directly supporting Aseptic Manufacturing.
Strong understanding of EU GMP Annex 1, applicable FDA regulations (21 CFR Parts 610, 210, 211), and relevant aseptic processing guidance.
Demonstrated expertise in risk-management tools including contamination control strategy, pFMEA, HAZOP and What-If assessments.
Proven experience in EM data trending as a microbial SME and in conducting investigations associated with sterility assurance, media fills, EM excursions and EMPQ with CAPA development.
Excellent communication skills.
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