Biologics Groningen [Manufacturing Engineer]

Job Description

The business and site

Our site in Groningen is part of the world class Pharma Services of Thermo Fisher Scientific and we are looking for a new colleague for our Operations team . We operate in a sophisticated and highly regulated environment. You’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! You will have a real-world impact, and you’ll be supported in achieving your career goals. Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to state of the (including Single Use Technologies such as Single Use Bioreactors).

This type of facility has to follow rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulations.

Controlled production activities and compliance to cGMP rules, regulations and guidelines is critical for the suitability of the clients’ products and the license to operate for the site. The production activities have to be completed in an efficient and effective manner to assure the sites overall competitiveness. In addition, due to the very high value of intermediates and products, production activities have to be performed in a highly controlled fashion.

How will you make an impact?

Supporting in all aspects to support drug substance manufacturing such as facilitate technology transfer, preparing production documentation, deviation investigation management, leading continuous improvement projects, supports training and batch documentation review. Responsibilities include but are not limited to providing operations support to realize the site production plan, but also includes ensuring safe working conditions.

The Job

Thermo Fisher operates as a Contract Manufacturing Organization for small to large Pharma customers. Biologics exclusively focuses on production of antibodies and other active pharma proteins using mammalian cell lines. Customers are companies varying for having a product in the clinical stage of development up till commercial phase. This requires a short time to the clinic, i.e. a short but effective development of their process, followed by timely transfer to Operations and batch production under cGMP.

Production activities range from performing a totally new production run for the first time, to the routine production of a commercial batch. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse.

Controlled production activities and compliant to cGMP rules, regulations and guidelines is essential for the suitability of the clients’ products and the license to operate for the site.

Manufacturing Engineer has a responsibility to support the operations department where needed to realize the site production plan. The job holder will focus on the technology/process transfer (in the acceptor role), preparing production documentation, deviation investigation management, leading continuous improvement projects, training and batch documentation review. .The job holder will work in a team and needs good communication and interpersonal skills to achieve the overall team result. A pro-active attitude and personal initiative are expected to identify and overcome tactical and practical challenges!

Key Areas of accountability/responsibility

• Support in setting up material-, equipment- and resource plannings.

• Supports introduction new equipment (in the acceptor role).

• Design and preparing production documentation.

• Perform deviation investigations management (as part of first line trouble shooting) to determine Root Cause and to prevent reoccurrence.

• Lead continuous improvement projects – change controls (e.g. due to outcome of process/equipment Kaizens, CAPA and or Audit Findings)

• Perform batch documentation review.

• Supports in training of Operations teams.

You have/ are

• Master or Bachelor of Science (Bio) Process Technology, Biology, biochemistry

• Expert in English, both in oral and written communication.

• At least 4 years of proven experience in a (bio) pharmaceutical company

• Knowledge of pharmaceutical cGMP systems and relevant process unit operations (e.g. cell culturing, purification).

Competencies

• Problem-analysis

• Judgement

• decisiveness

• Written communication

• Persuasiveness

• Independence

• Initiative

• Results