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Senior Manufacturing Specialist

An amazing opportunity for a Senior Manufacturing Technician to join an exciting Biosimilars company based in Iceland has become available.

As the Senior Manufacturing Technician you will be responsible for providing expert knowledge and experience in all manufacturing activities involved in the secondary manufacture of finished products.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Manufacturing Technician will be varied however the key duties and responsibilities are as follows:

1.

Proactively establish collaborative, constructive and affable cross-functional working relationships as required to enable any issues arising in Manufacturing to be resolved/completed in a timely, efficient and effective manner.



2.

Determine equipment requirements via User Requirement Specifications and take part in Qualification and Validation activities e.g.

FAT/SAT, IQ, OQ, PQ and PV as required to assist adherence to manufacturing strategy milestones.

3.

Lead the execution of re-qualification and re-validation protocols to maintain the qualified status of equipment and processes as well as contributing to the smooth technical transfer of new processes/product into manufacturing.

4.

Step in and deputise for the manufacturing team leader when needed and be the subject matter expert.



ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Manufacturing Technician we are looking to identify the following on your profile and past history:

1.

Relevant degree in a scientific discipline such as Biotechnology, Biochemistry, Biochemical Engineering, Chemical Engineering etc.



2.

Proven industry experience in aseptic manufacturing of (in vial/pre-filled syringe) biopharmaceutical products within a GMP environment.



3.

A working knowledge and practical experience with URS, FAT, SAT, IQ, OQ, PQ would be highly desirable, along with experience of Pre-Approval Inspections and international regulatory agencies including the FDA and EMA.

Key Words: Biopharmaceutical | Manufacturing | Production | Fill/Finish | Validation | Biosimilars | Antibodies | Vials | Pre-filled Syringes | IQ | OQ | PQ |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science.

We look forward to helping you with your next career moves.