34153 - Aseptic Operations Engineer

Orion Group Life Sciences are currently recruiting an Aseptic Operations Engineer  on behalf of our Multinational Pharmaceutical client based in Sligo on an initial 12-month contract with strong potential to extend.
 
100% onsite role.
 
Your Purpose
As a member of the Aseptic Operations function, and as an Aseptic Manufacturing SME, ensures that Equipment for Aseptic Manufacturing (Equipment/Cleanroom/Utility) is designed according to company standards and industry best practice and is operating as designed. Partners with site colleagues and other members of the Site Aseptics team to create an environment of the highest performance standards of Aseptic Manufacturing. Drives continuous improvement in Aseptic Manufacturing Equipment on site.

Your Responsibilities (in addition to other duties as assigned)

• Acts as the Subject Matter Expert for Equipment, Cleanroom and Utility systems related to Aseptic Manufacturing.
• Responsible for ensuring that Equipment, Cleanroom and Utility systems required for Aseptic Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Aseptic Best Practice.
• Supports existing process engineering systems related to Aseptic Manufacturing to ensure they are operating as designed through:
  • Real-time monitoring of Cleanroom performance (e.g., temperature, relative humidity, differential pressure, air flow velocity, etc.)
  • Real-time monitoring of Utility performance
  • Real-time monitoring of critical equipment cycles (e.g., CIP, SIP, VHP, Aseptic Filling, Autoclaves, Lyophilization, Depyrogenation, Bulk Heat Sterilization, etc.)
  • Monitoring, investigation and addressing of automation alarms
  • Trending performance and developing/executing action plans as required
• Partners with other members of the Site Aseptics Team (e.g., Quality SMEs, Operations SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product.
• Participates in troubleshooting and investigations for equipment, cleanroom and utility-related events.
• Actively participates in 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.
• As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing Engineering systems and procedures through:
  • Continuously assessing, interpreting and applying new Aseptic Manufacturing Regulations to Site Engineering systems in a timely manner
  • Development and implementation of best practices in Aseptic Manufacturing
• Ensures Equipment, Cleanroom and Utility Design related to Aseptic Manufacturing is in compliance with company engineering standards and industry best practice through:
  • Providing key input into the design of systems
  • Ensuring extensive knowledge of the systems
  • Ensuring extensive knowledge of engineering standards
  • Ensuring that any deviation from engineering standards goes through the required approval process
• Leads projects related to equipment, cleanroom and utility equipment changes.
• Ensures all alarms are ranked according to criticality.
• Approves Preventative Maintenance strategy for Equipment, Cleanroom and Utilities.
• Ensures that all Engineering system changes follow Site Change Control procedures.
• Ensures appropriate use of Risk Management tools to drive Aseptic performance and Sterility Assurance.
• Supports regulatory audits as Aseptic/Sterility Assurance Engineering system subject matter expert.
• Anticipates and provides leadership to the Site Aseptics team, highlighting and leading the introduction of continuous improvement initiatives.
• Drives a high-performance culture in Aseptic Manufacturing and promotes a culture of Speak-Up.
• Participates in routine leadership GEMBAs of Manufacturing and Testing areas.
• Provides key input into Site Contamination Control Strategy, APS Strategy and Aseptic Manufacturing processes.

Qualifications & Experience

• Third Level Degree in an Engineering or equivalent discipline.
• 3+ years of experience in a GMP Environment with 1+ years of experience supporting Aseptic Manufacturing.
• Strong knowledge of Regulatory Requirements.
• Project Management experience.
• Excellent communication skills.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.