CSV Lead

NL1757

DPS Group Global is currently looking for a CSV Lead in Switzerland

Category:
Engineer Validation & Commissioning
Location:
Switzerland
Years of Experience Req.:
>2 years
Date Posted:
07/09/2020
Days Remaining:
6
Employment Type:
Contract
Education Level Req.:
Bsc or Msc degree

DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are; Pharmaceutical and Biotechnology, Medical Technologies, Oil & Gas, Advanced Technology, Science & Education, Food & Beverage, and Energy.

 

Job Description

A CSV lead is required for the Project to coordinate the following activities:

  • Lead CSV activities for equipment and integration of PLC based system into Delta V for numerous software package types.
  • Technical SME in relation to CSV integration activities and lead commissioning activities inclusive of Risk Assessment, Commissioning and Qualification document generation and execution, in line with project deliverables and schedule requirements under the supervision of the Project CQ Lead.  

 

Requirements

  • Leads CSV commissioning & qualification activities to achieve defined scheduled production start dates.
  • Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5 and ISO 13485:2003 requirements among others.
  • Perform Computer System Validation and other duties as assigned.
  • Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation.
  • Demonstrated ability to plan and organiz968265.698444e validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
  • Capable of independently discussing computer systems validation philosophies. Capable of correctly answering questions about day-to-day activities that would be most likely posed by more junior Validation Engineering personnel. 

 

Skills

  • Technical writing of commissioning and validation documentation for large scale CAPEX projects.
  • Working knowledge of ASTM-E2500 methodologies and CSV package integration of (Risk based Qualification) both fixed equipment and Single Use Technologies in GMP manufacturing environments.
  • Demonstrated working knowledge of validation principles and cGMPs, FDA, EMA, TGA, ICH and PICs regulatory requirements, compendia and guidelines such as ISPE.

 

 

Available and interested?

If you’re interested in this role and if you want to be part of growing organisation within engineering projects in the pharma industry or if you would like to discuss this vacancy further and to discuss your career options in confidence, please telephone Ralf Huisman on +31 6 11408791 or send your CV to ralf.huisman@dpsgroupglobal.com

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