Manufacturing Engineer (II)

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, Office

Job Description

Job Description

Manufacturing Engineer (II)

Business Unit

Biologics

Department

Operations

Purpose of the Job

Responsible in supporting the Drug Substance Manufacturing with preparing production documentation, planning, deviation investigation management, continuous improvement projects, supports training and batch documentation review and facilitating technology transfer. Responsibilities include but are not limited to providing operations support to realize the site production plan, but also includes ensuring safe working conditions.

Job and Position Context

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.

The technologies that Thermo Fisher offer are industry standard to innovative. (including Single Use Bioreactors). For each new product a manufacturing process is to be developed and optimized. Annually, 5-10 new manufacturing processes are transferred from the Process Development department to the Operations department. Next to that new technologies are acquired and/ or developed to keep and increase the competitiveness of Thermo Fisher. Processes developed in Process Development will be transferred to the cGMP facility in Groningen.

Production activities range from implementing 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.

The biopharmaceutical type of facility must align with 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 the internal and external EH&S requirements and regulations.

The production, NPI, Batch Disposition 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. Mistakes can cause high cost.

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.

Scientific: The job holder has a responsibility to support the operations department where needed to realize the site production plan. The job holder will focus on the process transfer (in the acceptor role), preparing documentation, deviation investigation management, leading continuous improvement projects, training and batch documentation review. The job holder may represent Operations in the Customer Core Teams to assure the above-mentioned focus areas. The job holder needs knowledge of mammalian cell culture or downstream processing and of quality systems sufficient to perform the assigned task. The job holder needs elementary knowledge on process design and scale up.

Organization: Within the Operations department the job holder is responsible for supporting the Operations department. The candidate works in a team and needs good communication and social skills to achieve the overall team result. A pro-active attitude and personal initiative are expected to identify and overcome tactical and practical challenges.

Networking: The job holder is operating in a wide network within and outside Thermo Fisher:

• Internal Thermo Fisher:
• Project Managers.
• MSAT representatives.
• Operations Technicians and Supervisors
• Quality Representatives
• Logistics Representatives
• Maintenance and Technical Support representatives
• Operational and Quality departments of Thermo Fisher
• External Thermo Fisher:
• Clients
• Suppliers

Quality and EH&S: Responsible for acting according to EH&S, Quality, and cGMP regulations. Production must be performed under safe conditions, while the health of the operators must be guaranteed and negative effects on the environment prevented.

Job Content Key Areas of accountability/responsibility

• Support at technology/process transfer.
• Supports introduction new equipment.
• Design and preparing production documentation.
• Perform deviation investigations management (as part of first line trouble shooting) to resolve 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)
• Review batch documentation to release product.
• Supports in training of Operations teams.
• Support Production Execution and Batch Disposition.

Authorities

NA

Complexity of the Job

The biopharmaceutical industry use of a wide range of technologies (including cell line generation, cell culturing and purification (DSP) technologies).

Highly skilled Operation personnel are needed to carry out the manufacturing activities. The main emphasis of this position is to proactively support operations to perform and improve the manufacturing processes. This implies that the jobholder has the ability to coordinate and understand the complete (high level) manufacturing process to be able to represent the operational needs during 1) technology transfer (process and /or equipment), 2) preparing documentation, 3) deviation investigation, 4) leading continuous improvement projects, 5) training 6) batch documentation review to ensure a smooth manufacturing process.

The role will l have frequent interactions with representatives from several departments. Frequent contact within Operations and with MSAT, QA, QC, Maintenance and Technical Support, Logistics are required. Each project is unique involving representatives of various departments and subject areas, is key for success.

Knowledge and educational level

• Master or Bachelor of Science [(Bio) Process Technology, Biology, biochemistry], or with equivalent experience in a similar field
• Proficient in English, both in oral and written communication.

Required Level of Experiences

• At least 3-6 years of proven experience in a (bio) pharmaceutical company
• Knowledge of pharmaceutical cGMP systems and relevant process unit operations (e.g. cell culturing, purification).
• Practical knowledge and understanding is desirable

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare support, and a range of employee benefits, 28 days off a year. 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!