Process Supporter with expertise in Manuel/Automated Visual Inspection

Your New Role

You will have a key role in building the processes and qualify the staff to operate them. Apart from the processes around the MVI and AVI you will support our MSAT department in qualifying the inspection line and systems around it.

In addition to your focus area in Visual inspection you will also support other main operational processes including wash and sterilization, formulation, filling.

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.

Primary tasks:

• Develop and maintain an efficient and stabile visual inspection area
• 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 and contribute to Risk assessments related to ongoing manufacturing and new products.
• 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

• A bachelor’s or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar degree.
• A minimum of 5 years of experience within GMP manufacturing in the Pharmaceutical/Biotech industry.
• Preferable experience related to Drug product manufacturing and PAS-X.
• You have a high level of technical writing skills
• 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 & Department

The Drug Product Manufacturing 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.

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. If you have any questions, please do not hesitate to reach out to Manager DPM, Kenneth Feltendahl Zeuner +45 41945503