Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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Job position summary
The incumbent will be taking accountability for maintenance activities (planned and unplanned), utilising operational excellence and continuous improvement activities to improve equipment reliability and ensure minimal equipment downtime. During maintenance incidents, the incumbent will actively use problem solving and lean manufacturing techniques to identify the true root cause of the issue - and implement corrective actions.
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Responsibilities
- Responsible for the operation and maintenance of sterile manufacturing process equipment but not limiting to formulation and fill machines.
- Draft validation protocol and complete the validation task in accordance with standard operation procedure (SOP) steps.
- Draft and prepare maintenance SOP and PM plan.
- Lead process equipment changes by working with a multi-functional team. This includes equipment improvement and format change parts request.
- Take up the role of deviation lead investigator and work with a multi-functional team.
- Support internal and regulatory audit. Be the manager fronting the regulatory auditor.
- Complete all routine maintenance, periodic review, routine qualification on time and in compliance with engineering standard, GDP requirement and safety.
- Carry out any other duties and responsibilities as assigned by the manager.
- Be familiar with change control and quality ownership.
- Utilise external resource, where appropriate, to acquire services/components, generating, completing and acquiring the appropriate documentation and approval to proceed (e.g. Purchase Orders, spares requests, quotations, etc.)
- Supervise and control spares in an efficient manner
Education
University degree in engineering
Experience
Proven experience in maintenance of sterile fill finish process equipment and its related validation.
SAP/CMMS knowledge is an advantage.
Proficiencies
Able to work in a fast pace and a regulated environment.
Able to plan, schedule, organise, prioritise and coordinate the work assigned.
Good understanding of production process and related validation/GMP requirements
Good equipment troubleshooting skill and a good knowledge of RCA tools.
Able to work independently and to hands on to perform machine maintenance work.