Process Engineer/Technical Operations Support
Process Engineer/Technical Operations Support - Schaffhausen
CK QLS are recruiting for a dynamic candidate to join a company in the pharmaceutical industry at their site based in Schaffhausen on a contract basis.
Process Engineer/Technical Operations Support Role: The main purpose of the role will be:
- Tech Transfer (TT) for New Product Introduction (NPI) for Drug Product manufacturing for both internal and external JSC manufacturing facilities, but mainly focused on the Schaffhausen site and regional Contract Manufacturing Organizations (CMO's).
- Life cycle management of Drug Product manufacturing, for both internal and external JSC manufacturing facilities, again mainly focused on the Schaffhausen site and reginal CMO's.
- Support for the Parenteral Centre of Innovation (PCI) and taking and an active role in global alignment and standardization of processes and procedures.
- Providing active support for products sourcing, Business Case development and general technical/operational programs.
Further responsibilities will include:
- Performing Technical Assessments, Process fit to plant, Risk Assessments.
- Interfacing with manufacturing organization and the Process Development (PD) organization.
- EquipmentPerformance Qualification, Cleaning Validation.
- Providing manufacturing technical support.
- Monitoring technical process and product performance, developing models and metrics to ensure production consistency, and regulatory compliance.
- Leading or supporting complex failure investigations (escalation of quality or compliance events).
- Providing technical support, in partnership with Operations and Quality for regulatory audits and inspections.
- Continued Process Verification, Process and Cleaning validation.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- At minimum a Bachelor's degree in a numerate discipline - Engineering or Science.
- Experience in a pharmaceutical environment is required, preferably over 5 years or more.
- Expertise in pharmaceutical manufacturing processes, products and equipment is required.
- Knowledge of Quality & Compliance, GxP systems, and knowledge of validation is required.
- Experience working or leading and influencing in a matrix type organization is preferred and in project management (FPX or similar), organizing, planning and coordination skills are required.
- Knowledge of regulatory requirements (GMP/EH&S) is preferred.
- Fluent in German And English.
Apply: For more information or to apply for this Process Engineer/Technical Operations Support position, please contact Adrien on 0044 (0) 1438 870 027 or email aguimard@ckqls.ch, quoting job ref 48716.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.
