CSV Engineer

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• Reporting to the Digital Project Manager and CSV Lead specifically responsible for Computer System Validation.
  
• 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 regulatory standards.
  
• Will be required to work closely with Digital teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
  
• Will review and ensure vendors compliance with quality standards.
  
• Will represent the CSV function at Automation IT and other project meetings as required.
  
  

Requirements

Role Functions:

• 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 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 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 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
  

Knowledge Skills Education & Location Requirements

• Fluent in English written and verbal.
  
• 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
  
• Usual place of work will be onsite. The successful candidate may sometimes be required to attend meetings at Vendor premises or other sites as required.
  
• 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 will be advantageous.
  
• Previous experience working with paperless validation systems (Kneat) will be advantageous.