CSV Project Senior Engineer
CK Group is recruiting for a CSV Project Senior Engineer to join a company in the Pharmaceutical industry at their site based in Ballydine on a contract basis for 11 months and has a hourly rate of €41.91.
The Company: 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 Location: This role will be working at the Ballydine site which exports to more than 30 countries, including Japan, the US and much of Europe. It produces active pharmaceutical ingredients (APIs) for use by subsidiaries throughout the world, including late stage clinical APIs. The site includes a formulation, R&D and manufacturing facility, which supports our clients initiative to bring new medicines to market more effectively. It develops innovative ways to formulate new products from pilot to commercial scale, and supplies tablets for late stage clinical trials, launch and early stage supply.
The Role: As the CSV Senior Engineer for the project you will manage subordinate CSV resources and provide clear direction for systems validation approach within the project. You will also develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy and develop templates for all SDLC deliverables, compliant with company 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.
Other key duties include:
- Work closely with the QA-IT function and ensure their requirements are met in all deliverables.
- Align with the company HPV program: leverage existing documents & expertise where feasible.
- Approval 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.
- Work closely with suppliers/integrators to ensure compliance with company standards.
- Participate in, and support, relevant project meetings.
- Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
- Expert knowledge of GAMP5.
- Strong experience in one or all of the following systems: PLC/SCADA systems, DCS, MES, OSI PI.
- Strong interpersonal and communication skills (verbal and written).
- Relevant Computer Science or Engineering degree or equivalent.
- Previous experience of Oral Solid Dose manufacturing will be advantageous.- Previous experience of high containment manufacturing will be advantageous.
For more information or to apply for this position, please contact Jenni on 01438 768 710 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 46743 in all correspondence.