Sterility Assurance Specialist

Desired Skills: Sterile Manufacturing,Aseptic Manufacturing

PE Global is currently recruiting a Sterility Assurance Specialist for a leading multi-national Biotech client based in Sligo.

This is an initial 12-month contract position.

ROLE:

• Acts as a Subject Matter Expert for Aseptic Manufacturing.
• Provides key input for setting up the Manufacturing process.
• Provides key input for the Manufacturing Batch Record.
• Responsible for ensuring that Operations procedures required for Aseptic Manufacturing follow relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
• Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance. Responsible for completing pFMEA and What If/ HAZOP assessments.
• Partners with other members of the Site Aseptic Team (e.g. Quality SMEs, Engineering SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe quality, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product.
• Drives a high-performance culture in Aseptic Manufacturing, through communication and colleague engagement. Drives a culture of Speak-Up.
• Routinely observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate, in particular during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling and Interventions.
• Actively leads and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• Owns analysis and trending of EM data (Facility and Personnel) include ownership of the EM Visualization tool and its standardized use across functions. Develops and executes action plans to address EM trends.  Provides key input to EM procedures.
• As part of the Site Aseptic Team, drives continuous improvement of Aseptic Manufacturing procedures through:
• Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site operations in a timely manner.
• Development and implementation of Best Practices in Aseptic Manufacturing.
• Ensures that all procedures and changes follow Site Change Control procedures.
• Provides key input into the Site Contamination Control Strategy.
• Provides key input into site APS strategy.
• Provides key input into Site LRP related to Aseptic Manufacturing.
• Provides key input into Cleanroom/ Equipment/ Utility design, Qualification and Re-Qualification processes, Preventative Maintenance strategies and real-time monitoring.
• Supports regulatory audits as Aseptic/ Sterility Assurance subject matter expert.
• Supports training of Operations personnel in Aseptic technique and in Aseptic processing related procedures.
• Participate in routine leadership GEMBAs of Manufacturing and Testing areas.

REQUIREMENTS:

• Third Level Degree in a Science, Quality or Engineering discipline.
• 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing (non-negotiable)
• Strong knowledge of Regulatory Requirements including EU GMP Annex 1 ‘Manufacture of Sterile Medicinal Products,’ FDA requirements including 21 CFR Part 610 (General Biological Products Standards), 21 CFR Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs) and 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and FDA guidance documents such as ‘Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.’
• Author and subject matter expert for risk management tools that drive aseptic performance / sterility assurance including contamination control strategy, pFMEA, HAZOP, What if?
• Experience in tracking and trending environmental monitoring data as microbial subject matter expert.
• Experience in investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• Excellent communication skills

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 86 3514962 or alternatively send an up-to-date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***