Manager

Description:

BMS Cruiserath Biologics is seeking an experienced Engineering professional to lead a Drug Product maintenance team. Reporting to the Senior Manager, Drug Product Maintenance and Reliability the Maintenance Manager will lead the Maintenance 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 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 start-up 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, and is responsible for corrective and preventative maintenance, troubleshooting and Technical Operations Support all equipment in a new Sterile Drug Product Manufacturing Facility.

The 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

Hire and develop a highly skilled, high performing maintenance team capable of supporting the full equipment lifecycle of a Sterile DP facility, from FAT execution and commissioning, qualification, and handover to Operations
Post Project handover, develop shift teams to support the 24/7 manufacturing operations.
Ensuring 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.
Perform advanced troubleshooting and repair of equipment and systems, including diagnosis and faultfinding of automation and controls.
Develop energy control plans for routine maintenance requiring control of hazardous energy
Use knowledge of sterile fill/finish process equipment to support Manufacturing, Quality, Automation, Validation, and EHS for Safety or Quality deviation investigations, change controls, and CAPA’s.
Manage CMMS work requests/work orders, including generation, processing, tracking and follow-up.
Engage with the Maintenance engineers and equipment vendors to develop maintenance and calibration programs, spare parts requirements, and technician training.
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.
Understand and implement HSA and Safety requirements of Maintenance teams and how they apply in normal sustaining operations or major shutdown/overhaul situations.
Building and maintaining relationships between key stakeholders, including Manufacturing Operations, Manufacturing Planners and EHS and ensuring there is a collaborative culture, process centric, with a ‘One team’ approach.
Work with Procurement on engaging with third party service providers and OEM equipment maintenance contracts.
Ensure the Production Planning schedule is cognizant of the maintenance schedule 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 in 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

A minimum of 5 years leadership experience in a similar scale pharmaceutical manufacturing site with 24x7 operations.
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, OR a trade background with significant relevant experience and additional training
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.
Ability to provide technical leadership to maintenance technicians.
Experience of operating and faultfinding PLC based control systems and vision systems.
Ability to read and interrogate mechanical/ instrumentation & process drawings.
Understanding of HSA and Safety requirements of Maintenance teams and how they apply in normal sustaining operations or major shutdown/overhaul situations.
Working knowledge of Machinery Directive and Atex Directive and how it applies to the maintenance and operation of a manufacturing plant
Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.
Experience in multiple ‘ways of working’ and able to contribute to final Organisational Structure design.
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.