Aseptic Filling Supporter (12 Months - Maternity cover)

Your New Role

We are looking for an experienced filling supporter who also has basic knowledge of main operational processes including wash and sterilization, formulation and manual/automated visual inspection. You will be part of our support organization which is responsible for implementation of operational processes and creation of procedures within the DP manufacturing area. You will support and participate in the design and creation of our electronic Master Batch Records. Work in close cooperation with our stakeholders to get all supporting documentation ready for operation and support Tech Transfer activities for the DP area. The team is also responsible for supporting the daily operations in the DP area. This role includes a scheduled, compensated on-call rotation to ensure service continuity.

Primary tasks will be:

• 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 colleagues.
• 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 & Skills

You have a bachelor’s or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar degree. As a minimum you have 5 years of experience within GMP manufacturing in the Pharmaceutical/Biotech industry. Preferably you have experience related to Drug product manufacturing and PAS-X. You can work independently on compliance related tasks, events, and optimization projects. You are able to manage multiple stakeholders and are motivated by the interface between QA, MSAT and Manufacturing. You understand and are able to execute against regulatory requirements. You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

Your New Team & Department

The Drug Product Manufacturing department consists of approx. 50 dedicated and enthusiastic employees divided into three areas, DPM shopfloor, DPM Process support and DPM Wash & Sterilization and Area support. You will be a part of DPM Process support consisting of 11 highly skilled and committed supporters. The common denominator of the four teams is the acknowledgement and development of each employee and the diversity of the employees who have different experiences and educational backgrounds but collaborate closely on getting our medicine safely and quickly to the market.

Application

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. Deadline will be August 2nd.