Sterility Assurance Engineer

1 week ago

Singapore THERMO FISHER BIOPHARMA SERVICES PTE. LTD. Full time

**This is a 6 months to 12 months contract role**

At Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

**Position Summary**:
The Sterility Assurance Engineer delivers the Quality on The Floor program, providing end-to-end QA oversight of the site manufacturing facilities and support functions. The role is hands on, you will assist in the early identification and resolution of issues, the timely and accurate review of GMP records and training others on quality assurance concepts and tools. Assisting with internal, client and regulatory audits will be encouraged to ensure compliance with cGMP requirements. The role will require shift work to support continuous operations. Please note this role will involve working shifts at our 24/7 site operation.

**Responsibilities**:

- Provide QA guidance to operational activities across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing, and operations support.
- Supervision of clean rooms and support areas; compliance to SOPs - including actual entry into the clean rooms and maintenance of a minimum of a L1 license.
- Review and approval of a wide range of GMP records, supporting the manufacture and release of sterile products to the marketplace.
- Generate and review quality records e.g., Deviations, Investigations, CAPA and Change Controls.
- Lead and participate in local area & system-based audits.
- Training/mentoring of Operations staff & QA peers.
- Facilitate and attend daily operational meetings, planning and problem-solving activities.
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times.
- Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.

**What Experience / Qualifications are we looking for?**
- Relevant science-based degree, e.g. Chemistry, Biology, Pharmacy preferred with minimum 5 years of experience.
- Experience working within the pharmaceutical industry, in the manufacture of sterile products.
- Good knowledge & understanding of cGMP & other regulatory guidelines for the pharmaceutical sterile manufacturing industry.
- Excellent interpersonal skills with the ability to appropriately challenge behaviours at all levels of the organization.
- Good organizational and time management skills.
- Proactive approach to continuous improvement and project work.
- Problem solving skills with validated ability to anticipate problems, prioritize, analyse relevant factors and develop action plans.

At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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