Automation CSV Engineer
- Denmark
- Contract
- CAPEX Projects
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for an Automation CSV Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Generate any needed automation Validation Plans based on the corresponding for the projects.
- Generate and execute Automation Commissioning and Qualification test protocols for the Automation systems in scope of the project
- Support and participate in system testing
- Clarify discrepancies and review/approve executed test protocols
- Secure right quality strategy related to requirement and design documents and quality activities.
- Secure a good and common structure for the CSV solutions.
- Coordinate and collaborate with CQV related to strategies, solutions, and time frames.
- Coordinate and collaborate with site SME’s and end users to obtain necessary buy in.
- Comment/challenge and coordinate review of design documentation.
- Experience with DCS systems, preferably Emerson’s Delta V system
- Solid process understanding combined with automation understanding
- Experience from the pharmaceutical or biotechnology industry.
- Knowledge of batch processes, GMP, GAMP and the S88 standard.
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#LI-ML1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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