CSV Project Engineer
CK Group is recruiting for a CSV Project Engineer to join a company in the Pharmaceutical industry at their site based in Carlow on a contract basis for 11 months.
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The role is based at our client's site in Carlow, Ireland. Carlow is a fascinating town which pre dates written Irish history, has played a major part in Irish history and even served as the capital of the country in the 14th century. Carlow is located approximately 50 miles from Dublin and has good rail links as well as being close to the N9 & N80 roads.
- Responsible for CSV
- The engineer will be responsible for the development of key AIT documents, such as QA and test plans for ensuring to the QAP;s
- Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
- Develop templates for all SDLC deliverables, compliant with MSD standards, to ensure consistent implementation of the validation strategy, including but not limited to:
- Requirements Specification
- Requirements Traceability Matrix
- Functional Specification
- Design Specification
- Code Review
- Test specification/test script
- Work closely with the QAIT function and ensure their requirements are met in all deliverables
- Approver of all AIT SDLC deliverables, ensuring compliance with standards
- Provide FAT oversight and perform leveraging assessments,
- Provide guidance and support to AIT team members tasked with delivery of SDLC documents
- Provide input to the development of realistic project schedules and document trackers
- Fluent in English, written and verbal.• Minimum of 3 years' experience in a similar role, ideally in the Pharmaceutical industry.
- Expert knowledge of GAMP5.
- Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
- Relevant Computer Science or Engineering degree or equivalent
For more information or to apply for this position, please contact Natasha on 01246 457725 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46162 in all correspondence.