Process Specialist
Do you have an eye for detail and enjoy working with the latest technology and state-of-the-art equipment in a versatile project team? This could be something for you! The position is based in the Greater Copenhagen area.
Main Responsibilities:
As Process Specialist, you will be the cornerstone of the process engineering team;
- Design, Specify and install new process equipment and provide technical support and troubleshooting for Cell Culture (Upstream), Purification (Downstream), Clean Utility/CIP and Solution Preparation at specialist level.
- Manage, provide direction and ensuring a smooth cooperation with engineering providers, vendors, project disciplines and User teams.
- Reviewing URS’s, technical documents, and validation material. Challenge technical changes and ensure best possible solutions are approved and implemented.
- Support in development of Design supervision/guidance/review
- Installation supervision and collaboration with the commissioning team
- Scoping and implementation of equipment modification
- Drive changes including performing risk assessments, technical troubleshooting for all purification equipment
- Review validation protocols and support commissioning and validation testing and perform training to the production teams
Requirements:
· Minimum a Bachelor’s Degree within engineering or similar discipline
· 10-15 years of experience in the areas of GMP manufacturing, engineering, or facilities in a pharmaceutical environment
· A team player but also comfortable working independently
· Experience with project management and risk management
· Ability to navigate in complex project settings
· Self-driven and curious with a go-do attitude
· Experience with equipment in a commercial GMP environment
· Fluent in spoken and written English
Are you curious to know more about the position, do not hesitate to contact us. All applications must be submitted in English and are treated confidential.
Submit your CV and resume in the below form
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ABOUT APTIO GROUP
Aptio Group
consultancy is an agile & innovative Life Science Consulting Company with a
keen focus on the pharmaceutical industry. We are built on a simple business
model leading to efficient deliveries of our services within pharma, biotech,
and medical device. Our experienced engineers are specialized Life Science
consultants working with some of the biggest pharma and biotech companies in
Denmark and the EU.
Our main
headquarters is placed in Hillerød, Denmark but our consultants and engineers
are working at customer facilities around Denmark and the EU.
Originally Aptio
Group ApS was part of the leading consulting group, SIGMA in Sweden, founded in
2016, and then expanded to Denmark in late 2018. Today, we are no longer part
SIGMA but powered directly by Danir Group.
Aptio Group’s
success relies solely on our relations with our colleagues and clients. If you
want to be a part of shaping the future of consultancy, then Aptio Group is the
right place for you.