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Maintenance Area Lead

Location Cork, Ireland

Who We Are

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 Area Lead  -Shanbally, Ringaskiddy, Cork (onsite)

Closing date 9th February 2024

The Maintenance Area Lead is a role based in Maintenance Ops 

Reporting to the Maintenance Operations Manager, the primary role of the Maintenance Area Lead is to manage the daily maintenance operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.

There is one role to be filled and is based on high level description as follows:

One Maintenance Area Lead will be responsible for maintenance activities in Utilities incl HVAC, WWTP, Labs, Cold Store, Warehouse and Project expansions in these areas.

One Maintenance Area Lead will be responsible for Drug Product Manufacturing, Packaging and Project expansions in these areas.

One Maintenance Area Lead will be responsible for Drug Substance Manufacturing and Calibrations and Project expansions in these areas.

There are synergies between the roles and it is envisaged that some resources may be shared to ensure the business needs are consistently met.

Two existing MALs occupy roles but may move role depending on the successful candidate for this application. This will be assessed during the recruitment stage.

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.

RESPONSIBILITIES

People management of up to 15 direct reports comprised of Shift technicians, Day Technicians and Apprentices. Responsibility for development, coaching, appraisals and performance management. Addressing Technician and apprentice escalations.

Partner with Maintenance Ops Planning and Scheduling (P&S) to ensure planned works are executed and impact of reactive work minimized. Co-ordinate customer requirements with P&S.

Respond to relevant area escalations and assess reactive work requests to maximise both plant and maintenance resource efficiencies

Engage in the Continuous Improvement processes and partner with SME’s from Engineering team to ensure PM’s are optimized. Strong focus on visibility of Maintenance metrics on maximizing plant uptime and CMMS PM compliance.

Maintenance Area Leads to enhance team training and development of core competencies, ensuring training and practices are consistent throughout the organisation

Optimisation of the Apprenticeship Programme

Lead and support daily operation of plant and partner with colleagues in designated area departments to ensure equipment is maintained.

Instill the use of Right First Time (six-sigma) and lean practices (RCAR,5S etc) leading to operational excellence. Coach, mentor and train technicians on relevant maintenance works, use of operational excellence tools and instill high performance team behaviours.

Proactively maintain process, utility and facility equipment in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the reliability agenda.

Manage external vendor support to complete required services in a GMP compliant manner.

Ensure Electrical, Process and Utility Systems are maintained in a controlled state thus ensuring compliance with all procedures and regulations and reliability initiatives.

Maintain a safe working environment by continuously promoting safety awareness, recognising and rectifying unsafe conditions and performing thorough investigations when accidents occur.

Ensure Technicians record all maintenance work performed on the site CMMS system.

Ensure Technicians are trained to respond to critical utility alarms generated from the site automated alarm messenger system.

Maintain documentation and management of control systems in compliance with cGMP regulations and training instructions.

Network with Calibration Lead to ensure calibrations executed where required in timely manner.

Contribute to the drive to effectively manage spares, consumables and contracts in a timely and cost-effective manner.

Participation in HAZOP and design review (where applicable).

Execution of deviations, CAPA’s and SIMS (where applicable).


SCOPE

This position ensures the Plant equipment and instrumentation is maintained & operated in the state necessary to perform cGMP activities.


EDUCATION AND EXPERIENCE

A relevant time-served apprenticeship or third level qualification in Engineering with 5+ years’ experience in a GMP environment, preferably Bio-pharmaceuticals or equivalent industry.

Demonstrated experience working with MFG processes in production including hands on experience

Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred.

Track record of embedding a strong Quality culture. Trackwise experience preferred but not essential.

Demonstrate strong communication skills and the ability to interact across cross-functional teams.

Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.

Experience with regulatory inspections and direct interaction with regulatory inspectors.

Highly developed organizational and leadership skills.


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.


SUPERVISOR RESPONSIBILITY

Each Maintenance Area Lead of a given functional area will typically have ~10-15 direct reports; Technicians and Apprentices. The Maintenance Area Leads responsibility including a full rotating 24 hour and weekend shift operations. The role may require the successful candidate to respond to calls to support activities out of hours and process escalations as applicable

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.




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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