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Verification Lead

  1. United States
Michigan
  1. Contract
Competitive
  1. CAPEX Projects
08-03-2024
33496

This vacancy has now expired

C&V Filling Line Systems Verification Lead - Pharma - 9-Months Contract 

Do you want to work with an exciting company who are an established market leader within their unique and niche field? We have a fantastic opportunity for a C&V Filling Line Systems Verification Lead with 7 years experience to drive the delivery of a large new capital invest project on an initial 12-month contract. As C&V Filling Line Systems Verification Lead you will play a key role in the successful delivery of a new state of the art facility.


Responsibilities:
  • Preparation of all Verification Documents for all systems within the Filling Line Area. This will include Risk Assessments (SRA)/ Design Qualification (DQ) Reports)/ Sampling Plans/ Verification Test Protocols (VTPs)/ System Acceptance and Release Reports (SARR) - per the C&V schedule
  • Filling Line systems include a Bausch + Ströbel Vial Washer, Depyrogenation Tunnel, Vial Filler, First-In First-Out (FIFO) Conveyor, Capper and Tray Loading Machine, installed at PGE MAP Kalamazoo. All Filling Line equipment is installed under a SKAN ISO 5 isolator.
  • Ensure that all documentation required to complete all C&V activities for their area is prepared in advance of field need dates.
  • Participation in Safety Management for their Filling Line systems during System Start-Up & Commissioning execution – including Risk Assessments/ Method Statements/ Permitting/ Lock-out Tag-out (LOTO).
  • Participation in Mechanical Completion process on their assigned systems, including System Walkdown/ Punchlisting/ Turnover Pack Review/ etc. with CMT.
  • Co-ordination and execution of all C&V Field Execution activities for their assigned Filling Line systems. This will include resource coordination, i.e., Automation/ Craft support/ Operators/ Vendor/ Specialist Contactor, etc., and consumables coordination.
  • Review and Approve Permits for all activities on their assigned systems during the C&V phase.
  • Sign Permits, as C&V Owner, for all activities on their assigned systems during the C&V phase.
  • Ensure Vendor RAMS (Risk Assessments/ Method Statements) are approved for works to proceed.
 

Required Skills and Experience:
  • A minimum of 7 years commissioning and start-up experience on Filling Line systems, i.e., Isolator, Vial Washer, Depyrogenation Tunnel, Vial Filler, First-In First-Out (FIFO) Conveyor, Capper and/or Tray Loading Machinesideally in the Life Sciences Industry.
  • Experience on Large Scale Capital Projects.
  • Proven knowledge of C&V methodologies and current industry guides and practices.
  • Strong capability to collaborate with system stakeholders, including C&V, Engineering & Automation personnel.
  • Strong communication skills (verbal and written) and the ability to articulate ideas to influence others.
  • Good problem solving / troubleshooting skills.
  • Experience with SCADA and BMS Automation systems.
  • Good team member.
  • Proficient in spoken and written English
 
If this role is of interest to you, please apply now! 

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