LSC have a great contract opportunity for a CSV Engineer to join a top pharmaceutical company based in Tipperary.
If you have a 3+ years of working in a CSV role in a regulated environment are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- The CSV engineer will be responsible for the development of key quality documents, such as Quality Assurance (QAPs) test plans, Requirements Traceability Matrices and Quality assurance summary reports, ensuring adherence to MSD and regulatory standards.
- Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital projects, as defined by the CSV lead.
- 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
- Etc.
- Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met in all deliverables
- Approval of all Digital SDLC deliverables, ensuring compliance with standards
- Provide FAT oversight and perform leveraging assessments
- Provide guidance and support to Digital 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 site 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 Digital validation requirements
- ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 3 years' experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.
- Expert knowledge of GAMP5.
- Experience in the following systems is essential; Emerson DeltaV
- Experience in the following systems would be advantageous; DCS, Siemens PLC/SCADA, OSISoft PI, Werum Pax-X
- Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
- Strong interpersonal and communication skills (verbal and written).
- Relevant Computer Science or Engineering degree or equivalent
- Previous experience working with MSD will be advantageous.
- Previous experience working with paperless validation systems (Kneat) will be advantageous.
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding.Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
