Aseptic Control Lead

Aseptic Control Lead

BioMarin

Cork, Ireland

SUMMARY DESCRIPTION

We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. With the introduction of a new Drug Product, Fill Finish Facility, and Sterility Testing capability, utilising Isolator Technology and Vaporised Bio-decontamination Systems we require an experienced Aseptic Control Lead.

The primary role of the Aseptic Control Lead will be to support Drug Product Filling Operations by providing Microbiological, Technical and Compliance support to ensure Aseptic Control of DP Fill Finish Operations and testing.

SKILLS/ KNOWLEDGE/ BEHAVIOURS

The role includes but is not limited to the following:

  • Implementation and Maintenance of the Contamination Control Strategy and associated risk assessments;
  • On the floor support and Subject Matter Expert to partner with DP Operations to enhance bio-decontamination prevention and control;
  • Identifying and Leading Process Improvements;
  • Support training on cleanroom behaviours and aseptic processing is isolator systems;
  • Troubleshooting contamination events/ investigations – eg. Media Fill, Bioburden, Sterility, Environmental Monitoring, Utilities;
  • Experience in Change Controls, Investigations (RCAR) and deviations, Quality Risk Management;
  • Experience in Drug Product Fill Finish Facility;
  • Knowledge of Isolator Filling systems and VHP decontamination;
  • Monitor and Support Aseptic Process Simulations Media Fills;
  • Support Regulatory Audits;
  • Proactive team member looking for opportunities to improve current systems and process;
  • Ability to collaborate with other BioMarin departments (Drug Product Operations, Quality Assurance Validation, Facilities, etc.);
  • Excellent communication skills both written and verbal;
  • Excellent technical writing skill and experience in writing SOPs/ QRAs;
  • Experience with electronic systems – Veeva, Trackwise, MES;
  • Takes personal responsibility for timely delivery of tasks to the highest quality;
  • Self-motivated and ability to work under pressure;
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment.

EDUCATION

  • B.Sc. in a scientific discipline with 5+ years of cGMP experience in a relevant Microbiological role preferably in an aseptic environment or supporting aseptic manufacturing;
  • Good working Knowledge of the US and EU GMP and Safety Compliance regulations, eg Annex 1.

EXPERIENCE

  • Ability to work independently and meeting established timelines;
  • Comfort with coordinating the activities with other staff members;
  • Comfort with working in a team environment;
  • Previous experience interacting with Regulatory agencies desirable.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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