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Sterile Manufacturing Technician

4 weeks ago

Cork, Cork, Ireland BioMarin Pharmaceutical Inc. Full time
Overview

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Sterile Manufacturing Technician - Shanbally, Ringaskiddy, Cork

Onsite Role - 3 Shift Rotation

The Sterile Manufacturing Technician will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.

Role Summary

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.

As part of establishing sterile filling operations at the Shanbally facility, this role will play an important part in the start-up of the facility including tasks such as; attend equipment FATs, develop SOPs and batch records, generate training and qualification programmes, support equipment and process validation activities.

Once start up is complete, the Sterile Manufacturing Technician will perform recombination and pooling of drug substance; filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities. This role will also have responsibility for operation of the parts washer and autoclave. Responsibilities also include root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and/or corrective actions.

Responsibilities

The ideal candidate will be able to demonstrate a proven track record in a quality-focused, operational GMP environment where attention to detail and commitment to the task at hand is key. Previous GMP Sterile Filling experience is required with a strong preference for candidates with isolator vial and syringe filling experience in a start-up environment. Previous experience in a leadership role or senior technician role is preferred.

Reporting to the Drug Product Team Lead, the successful candidate shall work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility.

The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others.

This role requires flexibility with regards to work schedules. This role is currently a 3-Shift position with potential for future shift work changes as required:

  • 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 which are accurate, attributable, complete, legible & clear, original, timely & prompt.
  • 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.
Experience

Previous experience in a highly regulated sterile filling facility is required.

  • Previous experience of syringe and vial sterile filling and visual inspection in a start-up environment 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.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


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