Days Technician, Sterile Drug Product Clean Utilities

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Position Summary

BMS Cruiserath Biologics is seeking an experienced Engineering professional to join the Drug Product maintenance team. Reporting to the Manager, Sterile Drug Product Clean Utilities Operations & Maintenance, the Days 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 Days 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 Days 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 is a days role.

 Key Responsibilities

·         Reporting to the Manager, Sterile Drug Product Clean Utilities Operation and Maintenance to support delivery of an effective maintenance program to ensure process equipment operates in a safe and reliable manner.

·         Develop Standard Operating Procedures (SOPs), Work Instructions (WIs), Risk Assessments (RAs), Job Plans (JPs), Preventative Maintenance (PM) etc. for the effective and safe completion of maintenance tasks.

·         Work with the project & CQV team to facilitate delivery, validation, and safe operation of equipment associated with Clean Utilities.

·         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 Clean Utilities and 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.

 Qualifications & Experience

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 and/or Clean Utilities.

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

#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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601790 : Days Technician, Sterile Drug Product Clean Utilities