Qualification / Validation Engineer

Germany  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Qualification / Validation Engineer



 Our biopharmaceutical manufacturing client has undertaken a large remodelling project of its manufacturing facilities to allow for its first commercial production runs. The equipment and process engineering team is currently looking for a Qualification / Validation engineer to support them with a number of remediation projects to get the site ready for FDA inspection.



Job and Project Description



- Support on an ongoing remediation programme to review qualification, validation and other production documentation.

- Gap analysis of existing documentation for compliance with GMP, FDA and client internal guidelines.

- Hands on writing and review of documentation.

- Support in developing ongoing strategies for qualification and validation of equipment and automation systems.

- Generation of qualification and validation plans and reports.

- Completion of existing qualification remediation activities.

- Work closely with the existing qualification / validation team.



Requirements



- Comprehensive knowledge of technical and regulatory compliance requirements including GMP and FDA.

- Comprehensive understanding of manufacturing in the (bio-)pharmaceutical industry.



- Strong experience of qualification of pharmaceutical manufacturing equipment ideally including one or more of:



- Upstream Biopharmaceutical equipment.

- Downstream Biopharmaceutical equipment.

- Clean rooms.

- Autoclaves.

- Soft skills: team player; hands on and task orientated approach; self-dependent; strong problem solving abilities.

- English and German language essential in written and spoken form. 
Start date
n.a
From
Quanta Consultancy Services
Published at
12.12.2015
Contact person:
Lee Mitchell
Project ID:
1036938
Contract type
Freelance
To apply to this project you must log in.
Register