Lead Manufacturing Engineering Technician

Work Schedule

Other

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.). Standing for full shift.

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 growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding 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.

• Please note: This is a 12 hours monthly rotating shift role.

Position Summary

The incumbent will support site-wide routine operation and preventive maintenance, ad-hoc corrective maintenance to process equipment, utilities, and facilities systems. The incumbent may also be required to support equipment/instrument calibration and performance. Aligning with cGMP, EHS, Data Integrity, and regulatory requirements is a must for all tasks.

Responsibilities

• Participate in problem-solving discussions with a multi-functional team to identify/define root cause, evaluate alternative solutions, and develop action plans.
• Execute the routine maintenance for the site utilities systems, production equipment, control systems, automated filling lines, packaging, etc. in a timely manner and in compliance with Engineering standards and safety procedures.
• Complete training provided timely to improve proficiencies.
• Contribute to team effort by achieving desired results/important metrics. Share knowledge and mentor colleagues to build up their proficiencies.
• Manage third-party vendor who is contracted to perform routine preventive maintenance, corrective maintenance, and any other maintenance-related activity.
• Ensure all GMP documentation related to maintenance activities is completed accurately and processed to full completion in compliance with data integrity requirements.
• Carry out any other duties and responsibilities as assigned by supervisor, including but not limited to the above.
• Sterile manufacturing experience in maintaining equipment such as filling, autoclave, and part washer.

Minimum Requirements/Qualifications

• NITEC or Diploma in Engineering related qualifications.
• Minimum 5 years of experience in the pharmaceutical industry, biopharma, and medical devices.
• Strong understanding of facilities and utilities systems and process equipment related validation/GMP requirements.
• Strong electrical knowledge is essential.
• Safety certificates, example, confined space, will be an advantage.

Competencies

• Able to work in a fast-paced and regulated environment.
• Able to plan, schedule, organize, and prioritize day-to-day activity.
• Having a strong knowledge of various RCA tools and skills.
• Able to work independently.
• Able to work rotating shifts.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.