Maintenance Technician - Calibrations
Location Cork, Ireland Workstyle Hybrid ApplyWho 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.
Maintenance Technician - Calibrations
Shanbally, Ringaskiddy, Cork
Onsite Role
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.
The Maintenance Technician - Calibration reports to a Maintenance Area Lead. They are responsible for executing calibration activities plant wide in a GMP compliant manner. The Calibration Technician calibrates equipment in all site areas including drug substance, drug product, packaging, warehouse, utilities and laboratories
Responsibilities:
- Proactively maintain process, utility and facility equipment in calibration in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the site calibration program.
- Interact with all process partners to continuously improve operations by recognizing and correcting the causes of less than optimal equipment and facility performance.
- Manage external vendor support to complete required calibration services in a GMP compliant manner.
- Perform problem solving including root cause analysis as required when equipment failures result in loss of production, substandard equipment performance and substantial repair cost and/or personnel safety incidents.
- Maintain a safe working environment by continuously promoting safety awareness, recognizing and rectifying unsafe conditions and performing thorough investigations when accidents occur.
- Record all calibration work performed on the site CMMS system.
- Maintain documentation and management and control systems in compliance with cGMP regulations and training instructions.
- Where required complete and record calibrations activities completed on site and report any defects detected.
- Contribute to the drive to effectively manage spares, consumables and contracts in a timely and cost effective manner.
- Completion of all Calibration records in line with site SOPs.
- Control of handling of site calibration standards as per site SOP(s).
- Use of permit to work system or other safety systems to control engineering activities.
- Participation in HAZOP, design reviews and investigations.
- Participation in Continuous Improvement Program.
- Flexible to work additional hours should need arise
- Other duties as assigned.
Scope:
- This position ensures the Manufacturing, Quality Control, and Facilities equipment and instrumentation is maintained & operated in the calibrated state necessary to perform cGMP activities.
- Maintenance Technician - Calibrations has scope to initiate process, cost and execute continuous improvement ideas.
Education & Experience:
- A time-served apprenticeship with 3+ years’ experience or relevant third level qualification in Engineering or in a GMP environment, preferably Bio-pharmaceuticals or equivalent industry.
Contacts:
- Work cross functionally to deliver compliant, reliable, efficient and sustainable asset care for internal and external customers or as part of a multidisciplinary project team.
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.