Process Supporters To Drug Product Manufacturing

Process Supporters Wanted

Are you looking for an opportunity to join a growing pharmaceutical organization at a pivotal moment? At FUJIFILM Life Sciences Biotechnologies Denmark in Hillerød, we are entering an exciting phase where our Drug Product Manufacturing Facility is coming into operation.

You now have the chance to be a part of this journey and contribute to filling the facility with new products, Genki and purpose.

We are currently looking for Process Supporters to join our team. You will play a key role in helping us onboard new products and support operations in our DP manufacturing area.

Your new role will involve:

• Develop and implement operational documentation package (SOP's and WI's)
• Design and built electronical Master Batch Records (PAS-X)
• Participate and support the execution of qualification of equipment and processes.
• Participate and support activities related to initial and ongoing Aseptic Process Simulation (APS).
• Participate in Tech transfer activities and implementation of new programs for our area.
• Participate and contribute to Risk assessments related to ongoing manufacturing and new products.
• First line supporting role for DP operation including Training of colleges.
• Handling of events and deviations
• Continues Improvements on e.g. flows of personnel, materials and equipment, CMR's and document updates
• Identification and implementation of corrective and preventive actions (CAPA's) to prevent re-occurrence and improve compliance.

Your talent and skills should include:

• A bachelor's or master's degree within Pharmaceutical Sciences, Process Engineering, or similar degree.
• A few years of experience within GMP manufacturing in the Pharmaceutical/Biotech industry.
• Preferable experience related to Drug product manufacturing and maybee even PAS-X.
• Ability to work independently on compliance related tasks, events, and optimization projects.
• Ability to manage multiple stakeholders and is motivated by the interface between QA, MSAT and Manufacturing.
• Understanding and ability to execute against regulatory requirements.
• High level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

We hope you are curious of nature, meet and greet people with a smile and have a can do attitude. You work with humility and respect for the people around you. You are flexible and able to prioritize tasks to meet defined timelines. You work structured with a quality mind set and enjoy working independently and proactive in a dynamic entrepreneurial environment.

Your new team and department consist of approx. 50 dedicated and enthusiastic employees divided into three areas, DPM shopfloor, DPM Process support and DPM Wash & Sterilization and Area support.

Our ambition is that the Drug Product Facility will be state of the art, with automated isolator filling line and inspection line. The department continuously strives to identify opportunities to improve systems and practices to optimize and streamline our operation.

We are team players, entrepreneurs, and people who both like details and like taking greater responsibility beyond your scope of work. The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Has this sparked your interest? Then please upload your CV and cover letter as soon as possible as we screen candidates on a continuous basis and call in for interviews.

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.