Hyde Engineering & Consulting currently have a team of engineers onsite who are responsible for providing CIP Commissioning for our client in Denmark. We are actively recruiting additional support for this team, whose project will support our clients facility design, start-up and routine commercial manufacturing.
Responsibilities
• Perform commissioning and optimization of CIP skids.
• Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained site wide.
• Ensure project related work is carried out in accordance with the requirements of the clients validation policies, guidelines, validation plans and GMP.
• Provide on the floor support for troubleshooting cleaning verification/validation related issues and to lead manufacturing investigations into process deviations.
• Generation of reports / analysis of data against pre-determined criteria to GMP standards.
Knowledge and... Skills
• Minimum of 3 years’ experience of cGMP experience.
• Knowledge of cleaning validation experience within bio-pharmaceutical industry
• Experience with CIP skids
• Possession of interpersonal, team work and communication skills
• Demonstrated track record in the delivery of goals and improvements
Requirements
• Must be authorized to work in the EU
• Relocation and / or travel as this role is site-based
Hyde Engineering + Consulting is a global design and consulting organization providing process system design, commissioning and validation, FDA compliance, and state-of-the-art cleaning technologies to pharmaceutical, bioprocess and other regulated process industries for two decades.
Associate
Copenhagen Denmark