Jobs for People with MS: National MS Society

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of site expansion plan, the incumbent will be responsible for leading, implementing and handling all maintenance and facilities function for the Sterile Drug Products Filling facility in Singapore. This role manages a team of technicians and engineers that supports maintenance activities, set proficiency training, goal setting, and conduct performance evaluation.

A day in the Life:

• Review and approve equipment system design, Factory Acceptance Test (FAT), installation/ Site Acceptance Test (SAT), commissioning/ validation protocols.

• Be responsible for the site prevention maintenance, corrective maintenance and spare part management program.

• Manages maintenance service providers. Suppliers and vendors have to comply to site quality requirements.

• Build and update standard operating procedures/work instructions (SOP/WI) and other operation documentation. Ensure department Good Manufacturing Practise (GMP) procedures are in compliance with relevant company policies and regulatory requirements.

• Facilitate execution of related Out of specification (OOS) and Out of Trend (OOT), deviations, corrective and preventive action (CAPA) etc. related to quality.

• Act as facility and utility Subject Matter Expert (SME) during regulatory audit or customer audit.

• Lead and implement the site driven projects, managing subcontractors for successful execution of the maintenance program.

• Implementing site wide EHS procedures for maintenance activities and actively drive safety & Quality culture.

Keys to Success:

Education

Bachelor of Engineering with proven experience.

Experience

Good knowledge in GMP, Good documentation Practise (GDP), equipment and HVAC system operating in a sterile manufacturing environment.

Knowledge, Skills, Abilities

Solid understanding on equipment design, high reliability equipment performance and problem trouble shooting.

Experience on Commissioning, Qualification and Validation (CQV) is helpful.

Lead multi-functional team to drive objectives and goals.

Physical Requirements / Work Environment

The work environment is in a sterile manufacturing environment. At times, the work may require the incumbent to work on extended hours.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.