Website Asset Recruitment
CSV Engineer – Capital Projects
The CSV senior engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to company and regulatory standards. This candidate will represent the CSV function at project meetings and be required to work closely with Automation and IT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
• 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 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
• Work closely with the QA-IT function and ensure their requirements are met in all deliverables
• Company Align with the 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
Qualifications, Skills & Experience:
• Bachelor’s Degree in Computer Science or Engineering field
• Minimum of 5 years’ experience in a similar role in life sciences, ideally in Pharmaceutical manufacturing.
• Previous experience of API Manufacturing and/or Oral Solid Dose will be advantageous.
• Previous experience of high containment manufacturing (OEB4/OEB5) will be advantageous.
• Previous experience working with paperless validation systems (Kneat) will be advantageous
• Expert knowledge of GAMP5.
• Strong experience in one or all the following systems: DCS (DeltaV), PLC/SCADA systems, MES, OSI PI, Automated Utility Systems, Lab Systems, Building Automation Systems.
• 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).