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Manager, Sterile Drug Product Clean Utilities Operation and Maintenance
Manager, Sterile Drug Product Clean Utilities Operation and Maintenance-September 2024
Cruiserath
Sep 19, 2024
ABOUT BRISTOL MYERS SQUIBB
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Manager, Sterile Drug Product Clean Utilities Operation and Maintenance

  Working with Us

  Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

  Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

  Bristol Myers Squibb Ireland

  Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

  Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

  BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.

  Position Summary

  BMS Cruiserath Biologics is seeking an experienced Engineering professional to lead the Drug Product maintenance team. Reporting to the Senior Manager, Drug Product Maintenance and Reliability the Clean Utilities Operation and Maintenance Manager will lead the Clean Utilities team in delivering a safe working environment for our colleagues and a reliable plant to ensure continuity of supply of medicines for our patients.

  The Clean Utilities Operation and Maintenance Manager will be tasked with initially supporting the facility during project phase, building a team that can support equipment installation and commissioning, from initial specifications to final handover. Support will transition from project phase to operational phase to ensure a successful startup and commercialization of the facility, including GMP readiness and New Product Introductions.

  The Maintenance teams will also focus on complying with good engineering practices, company policies, regulations, and codes.

  The Clean Utilities Operation and Maintenance Manager will also support the Senior Manager, Sterile Drug Product Maintenance in ensuring that the Drug Product Maintenance teams objectives are aligned with the wider Engineering and Site Objectives.

  Key Responsibilities

  The Clean Utilities Operations & Maintenance Lead is responsible for the supervision and coordination of the utility shift operations team, including but not limited to HR related activities such as performance management.

  Work with the project teams to ensure maintenance requirements are considered during equipment design and sourcing.

  Support FAT execution and commissioning, qualification, and Validation as a member of the integrated project team.

  As required, the Utilities Operations Lead will report out on equipment status and

  availability and report any concerns regarding equipment/system integrity

  Oversee and optimise various clean utility systems, including Compressed Air (CA), Clean Steam (CS), Purified Water (PW), Water for Injection (WFI), loop, and Clean-in-Place / Sterilize-in-Place (CIP / SIP).

  Post Project handover, develop shift teams to support the 24/7 manufacturing operations.

  Work with the Maintenance engineers and equipment vendors to develop maintenance and calibration programs, spare parts requirements, and technician training.

  Work with site Reliability SME and Asset Life cycling to ensure maintenance programs are incorporated into site systems.

  Work with Reliability SME to develop trouble shooting skills and other foundational ‘ways of working’ to empower teams to problem solve in the field and advance the Reliability Excellence program.

  Work with the Mechanical, Electrical and Instrumentation SMEs and Technical Training to develop training programs, competency assessment and learning programs for the technical roles within the team.

  Work with site stakeholders on improving ways of working, scheduling, coordination with manufacturing operations teams.

  Work on building and maintaining relationships between key stakeholders, including Manufacturing Operations, Manufacturing Planners and EHS and ensuring there is a collaborative culture.

  Work with Procurement on engaging with third party service providers and OEM equipment maintenance contracts.

  Work with Quality team ensuring the team support all deviations, change controls CAPA’s in a timely manner

  Work with the EHS team to ensure Safety related Investigations and CAPAs are closed on time and with correct engineering rigor applied.

  Ensure the Production Planning schedule is cognizant of the maintenance requirements in the short, medium and long-term, ensuring major maintenance driven equipment outages are factored into the site long range planning.

  Assist Senior Manager in identifying, hiring, and developing a team to support the new facility during project phase and be ready to take maintenance ownership for the facility.

  Assist Senior Manager with development of annual Budgets and Headcount management for year on year and manage cashflow with Finance support.

  Work to consistently meet site metrics reflective of team’s performance and equipment reliability.

  Champion a safety culture within the Maintenance teams through pro-active methods such as Standard Operating Procedure execution monitoring in EHS and GMP area, and implementation of appropriate and effective training, ensuring operational activities are driven by the relevant Standard Operating Procedures.

  Qualifications & Experience

  Required

  A minimum of 8 leadership experience in a similar scale pharmaceutical manufacturing site with 24x7 operations.

  A multi-skilled individual with craft qualification in Electrical, Instrument or combined trades.

  Experience with a site start up and handover from CQV to Sustaining Operations, from a maintenance perspective.

  Experience in a regulated biopharmaceutical, pharmaceutical, medical device, facilities maintenance or FMCG facility with a good working knowledge of preventative maintenance programs for a wide range of plant equipment.

  Proven ability to prioritize maintenance activities and resources to achieve a safe and reliable site.

  Experience of operating and fault-finding PLC based control systems.

  Understanding of HSA and Safety requirements of Maintenance teams and how they apply in normal sustaining operations or major shutdown/overhaul situations.

  Demonstrated ability to influence work cross functionally in a matrix environment during start-up and into commercial manufacture.

  Ability to read and interrogate mechanical/ instrumentation & process drawings.

  Excellent communication skills and the ability to work as part of a multi-disciplined, cross functional team.

  High level of attention to detail in following procedures and must be flexible and open to change.

  Experience maintaining complex equipment in fast paced environment.

  Demonstrated experience and ability to effectively manage stakeholders.

  Excellent communication skills and the ability to influence others.

  Experience using SAP and budgeting tools.

  Desired

  Bachelor’s Degree in Engineering, Automation or equivalent experience in utilities or process controls, automation and/or information systems within manufacturing organisations in the Biotechnology or Pharmaceutical industries.

  Maintenance experience in Sterile Fill Finish.

  Why you should apply

  You will help patients in their fight against serious diseases

  You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

  You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus

  #LI-Onsite

  If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

  Uniquely Interesting Work, Life-changing Careers

  With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

  On-site Protocol

  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

  BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

  BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

  Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

  Company: Bristol Myers Squibb

  Req Number: R1576375

  Updated: 2024-01-19 14:03:42.610 UTC

  Location: Cruiserath,Ireland

  Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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