Aseptic Specialist (Operations)

Description

• Partner with Quality SMEs, Engineering SMEs, Aseptic MQA, and Aseptic Mentors to ensure manufacturing shifts have the support needed to complete product batches safely, compliantly, and in an aseptic manner.
• Support regulatory audits as an Aseptic/Sterility Assurance SME.
• Provide key input for the Manufacturing Batch Record.
• Own analysis and trending of Environmental Monitoring (EM) data, including responsibility for the EM Visualization Tool. Develop and execute action plans to address EM trends.
• Ensure all procedures and changes follow site Change Control procedures.
• Ensure Operations procedures comply with Safety and Environmental Regulations, Aseptic and GMP regulatory requirements, and network best practices.
• Lead and support investigations into sterility, media fill, EM excursions, and EMPQ issues, contributing to root cause and CAPA development.
• a) Assessing and applying new Aseptic Manufacturing regulations
• Drive continuous improvement of aseptic procedures by:
• Support training of Operations personnel in aseptic technique and aseptic processing procedures.
• Provide key input into Site LRP for Aseptic Manufacturing.
• Provide key input into the Site Contamination Control Strategy.
• Provide key input into the site APS strategy.
• Act as a site Subject Matter Expert (SME) for Aseptic Manufacturing.
• Provide key input into cleanroom/equipment/utility design, qualification, re-qualification, and preventative maintenance strategies.
• Routinely observe aseptic technique and behaviour of shift teams, giving feedback during critical activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling, and Interventions.
• Participate in routine leadership GEMBAs of manufacturing and testing areas.
• b) Developing and implementing best practices
• Provide key input into setting up the manufacturing process.
• Drive a high-performance culture through communication, colleague engagement, and a speak-up culture.
• Ensure effective use of Risk Management tools to support aseptic performance and sterility assurance, including pFMEA and What If/HAZOP assessments.

Requirements

Only candidates with a valid work visa for Ireland or an EU passport will be considered.

• Strong knowledge of EU GMP Annex 1, FDA 21 CFR Part 610, 210, 211, and FDA guidance “Sterile Drug Products Produced by Aseptic Processing - CGMP.”
• Third-level degree in Science, Quality, or Engineering.
• 5+ years in a GMP environment, with 3+ years supporting Aseptic Manufacturing (non-negotiable).
• SME-level experience with risk management tools including contamination control strategy, pFMEA, HAZOP, and What If.
• Experience tracking and trending environmental monitoring data as a microbial SME.
• Experience in investigations related to sterility, media fill, environmental monitoring excursions, and EMPQ, including root cause and CAPA.

Benefits

Rate: Up to €36 per hour

Training + Development

Interview process

Visa Sponsorship

Security clearance