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Sterile Manufacturing Technician

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Contract Type:
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Salary:

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Job Description:

The Sterile Manufacturing Technician will support commercial manufacturing for drug product manufacturing as well as, product transfers and operational readiness activities of new products. This facility contains a state-of-the-art flexible line using isolator technology for filling of vials and syringes and the facility supports both clinical and commercial filling for the majority of the BioMarin biologics product portfolio. BioMarin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.

Job Responsibility:

  • Perform recombination and pooling of drug substance
  • Perform filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities
  • Operation of the parts washer and autoclave
  • Root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and/or corrective actions
  • Complete both the manufacturing and visual inspection of sterile drug product as per the schedule
  • Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment
  • Perform all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures
  • Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation
  • Complete detailed batch record and GMP documentation entries
  • Perform environmental monitoring and routine batch sampling per applicable SOPs
  • Perform housekeeping duties
  • Maintain an exemplary personal training record
  • Pro-actively identifies compliance risks and takes appropriate preventative actions
  • Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and reoccurring issues
  • Proactively lead and support continuous improvement initiatives within the sterile filling facility
  • Provide leadership and guidance on shift to support and influence positive behaviour
  • Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required
  • Participate in/Lead cross functional team initiatives
  • Participate & support site inspections by regulatory agencies
  • Demonstrate commitment to a high level of safety awareness within the sterile filling team
  • Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards
  • Support Sterile filling equipment commissioning and qualification
  • Interface with external vendors & service providers

Requirements:

  • Previous experience in a highly regulated sterile filling facility is REQUIRED
  • Previous experience of syringe and vial sterile filling and visual inspection is highly desirable
  • A high mechanical aptitude and capability is desired along with technical experience
  • Candidates that can demonstrate a keen sense of focus and attention to detail when fulfilling exacting and repetitious tasks will have a distinct advantage
  • Must be conscientious and possess strong teamwork and interpersonal skills
  • Strong communication and problem-solving skills are highly valued
  • Demonstrated leadership skills in preferred

Nice to have:

  • Previous GMP Sterile Filling experience is required with a strong preference for candidates with isolator vial and syringe filling experience
  • Previous experience in a leadership role or senior technician role is preferred

Additional Information:

Job Posted:
January 09, 2026

Expiration:
January 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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