Job reference 82692
Manufacturing Associates (Process Operators) for the Drug Substance Manufacturing at Fujifilm Diosynth Biotechnologies
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For the Drug Substance Manufacturing Unit in Hillerød, Fujifilm Diosynth Biotechnologies is looking for Manufacturing Associates (Process Operators) to support the biopharmaceutical production operations.
FUJIFILM Diosynth Biotechnologies is currently expanding its capacity to support the large-scale production by adding 14 x 20,000L bioreactors and three downstream processing lines in Hillerød. The additional production capacity will make the facility the largest end-to-end Contract Development and Manufacturing Organization (CDMO) in Europe, offering a total of 20 x 20,000L bioreactors for drug substance production complemented by comprehensive drug product and finished goods services.
This is an excellent opportunity to join our company at a pivotal time of growth and be part of an exciting journey.
We are currently looking for candidates within our Drug Substance Manufacturing (DSM) for the two departments; Upstream and Downstream. These are covering different steps in the biopharmaceutical production such as Media/Buffer preparation, CIP, SIP of equipment, expansion of cell cultures, and purification via multiple column steps.
The common denominator of the departments is the acknowledgement and development of each employee. The teams consist of 10-20 Manufacturing Associates with different experience and educational backgrounds that collaborate closely on getting our medicine safely and quickly to the market, while staying true to our core values; Genki, gemba, delighting our customers and trust.
You will work on a day or night shift, 7 days during a 14-day period, including every other weekend.
Please add in your application which shift or shifts you prefer.
The work schedule is as follows:
Week 1: Monday, Tuesday, Friday, Saturday and Sunday
Week 2: Wednesday and Thursday
The shifts are as follows:
Day 1: 06:00 – 17:04
Day 2: 07:45 – 18:49
Night 1: 18:30 – 04:43
Night 2: 20:05 – 06:18
Please be aware that your first 6 weeks will consist of a training period, both onsite and offsite.
In the position as Manufacturing Associate, you will e.g., work on the following tasks:
- Execution and revision of cGMP documents
- Handling and completion of batch documentation
- In-process sampling and analytical measurements
- Execution of validation protocols
- Read and understand work instructions (in English)
- Training new colleagues
- Reporting deviations
- Possibility of being a part of different projects such as, process optimization, red lining SOPs, 5S and continuous improvement
We are looking for process operators, preferable with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate who have recently finalized their Bachelor or Master degree relevant for Biologics Manufacturing and are keen on starting their career in a manufacturing and international environment where things move fast.
It is a plus if you have experience with cGMP and/or SOPs or knowledge of chromatography and filtration processes.
You will get the opportunity to customize your development plan in agreement with your manager based on your wishes and qualifications.
We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools. You are very quality-oriented and thorough. You are proactive, responsible, organized and able to take ownership of tasks. Furthermore, you are a good team player who thrives on setting a good example. You must be keen on learning new things, and the first period will of course include thorough training.
If you are as excited as we are and believe this is the right opportunity for you, please submit your CV and motivation letter in English as soon as possible as we will have ongoing interviews finding the right candidates.