Process SME

Process SME - Life Sciences - Copenhagen - 12-Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Process SME to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.

Responsibilities:

Design, Specify and install new process equipment and provide technical support and troubleshooting for Cell Culture (Upstream), Purification (Downstream), Clean Utility/CIP and Solution Prep. – Specialist level.

Support General Contractor in development Design supervision/guidance/review.

Manage, provide direction and ensuring a floorless corporation with engineering providers, vendors, project disciplines and User teams. Writing /reviewing URS’s, technical documents, and validation material. Challenge technical changes and ensure best possible solutions are approved and implemented.

Participate in project meetings managed by General Contractor, Sub Contractors and the company

Installation supervision and collaboration with the company commissioning team

Act as Engineering SME you will be managing deliverables from the engineering partners and vendors, answering requests from internal and external stakeholders, and reviewing process documentation, equipment specifications and other engineering stuff.

Scoping and implementation of equipment modification

Drive changes including performing risk assessments.

Provide engineering technical troubleshooting for all purification equipment as required to support the project/production and secure reliable and robust operations.

Review validation protocols and support commissioning and validation testing

Perform training to ensure the production teams understand equipment functionalities.

Qualifications:

Minimum a Bachelor’s Degree within engineering or similar discipline

5+ years of experience in the areas of GMP manufacturing, engineering, or facilities in a pharmaceutical environment

Enjoy working as part of a team and being comfortable working independently.

Curiosity and strong sense of urgency

Self-driven

Experience working with equipment in a commercial GMP environment is a big advantage.

Fluent in English both verbal and written.

If this role is of interest to you, please apply now! 

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.