Shift Technician, Sterile Drug Product Maintenance

The Role

BMS Cruiserath Biologics is seeking an experienced Engineering professional to join the Drug Product maintenance team. Reporting to the Manager, Drug Product Maintenance, the Shift Technician will assist in delivering a safe working environment for our colleagues and a reliable plant to ensure continuity of supply of medicines for our patients.

The Shift Technician will be tasked with initially supporting the facility during project phase, supporting 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 Shift Technician will also support their manager in ensuring that the Drug Product Maintenance teams objectives are aligned with the wider Engineering and Site Objectives. They will be part of a multi-functional team charged with commissioning of the significant capital investment and upon completion of the project, they will support the sustaining operation on site.

This position will be initially on days but will move through various shift patterns as the project progresses to full commercial manufacture.

Key Duties and Responsibilities:

• Work with the project & CQV team to facilitate delivery, validation, and safe operation of equipment associated with Vial/Syringe filling and inspection.

• Ensure any maintenance and calibration activities are executed in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, Global Engineering procedures, as well as all Local Regulatory requirements.

• Understand and interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.

• Use your knowledge of sterile fill/finish process equipment to support Manufacturing, Quality, Automation,Validation, and EHS for deviation investigation, change controls, and CAPA’s.

• Manage CMMS work requests/work orders, including generation, processing, tracking and follow-up. Ensuring all Work Orders are completed on time and in a safe and compliant manner, and asset management data is captured accurately.

• Assist in advanced troubleshooting, and repair of equipment and systems. Including, but not limited to, diagnosis and fault-finding of automation and controls.

• Respond promptly and appropriately to any equipment failures / issues that may arise and provide guidance and solutions for preventative action where required.

• Execute planned maintenance routines including predictive, preventative and calibration activities.

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

• Collaborate with key stakeholders such as Manufacturing Operations, Manufacturing Planners and EHS.

• 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.

• Work with the Maintenance Manager to 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.

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

• Champion a safety culture within the Maintenance team.

• Assist the Maintenance Manager with any other maintenance work as per the business needs, including but not limited to development of training materials, vendor management, and other continuous improvement activities.

Required

• 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 is required.

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

• Experience of operating and faultfinding PLC based control systems.

• Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.

• 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.

Desired

• Bachelor’s degree in Engineering, Automation or equivalent experience in utilities or process controls, automation and/or information systems within manufacturing organizations 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, 27 days of annual leave, life assurance and on-site gym

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