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Verification Lead

  1. United States
Michigan
  1. Contract
Competitive
  1. CAPEX Projects
33495
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Classified Environments Verification Lead - Michigan - 12-Month 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 Classified Environments Verification Lead with 10 years experience to drive the delivery of a large new capital invest project on an initial 12-month contract. As a Classified Environments 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 the Facility, Qualified Areas, Isolator and Laminar Flow Units. This will include Risk Assessments (SRA)/ Design Qualification (DQ) Reports)/ Sampling Plans/ Verification Test Protocols (VTPs)/ System Acceptance and Release Reports (SARR) - per the project schedule.
  • 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 the systems within their remit during System Start-Up & Commissioning execution – including Risk Assessments/ Method Statements/ Permitting/ Lock-out Tag-out (LOTO).
  • Coordination, management, and execution of Functional Commissioning activities. Functional Commissioning activities include Final Balancing/ Differential Pressure Verification/ Drawing Walkdowns/ Documentation Verification.
  • Development of Risk Assessments and Sampling Plans, as per ISO 14644, for the testing of ISO 5 Isolators, and ISO 7 and ISO 8 Clean Rooms.
  • Oversight of Verification Field Execution activities. This will include resource management (C&V/ Automation/ Quality Control (QC)/ Vendor/ Operations) and test equipment and consumables management.
  • Sign Permits, as the Verification Phase Owner, for all activities on the systems within their remit during Verification.
  • Ensure Vendor RAMS (Risk Assessments/ Method Statements) are approved for works to proceed.
  • Oversight and support of Vendor SAT activities including SAT protocol pre and post approval.

Required Skills and Experience:
  • A minimum of 10 years’ experience in the pharmaceutical industry including Capital Projects, C&V and People Management experience.
  • Detailed knowledge of ISO 14644, EU GMP Annex 1 and US FDA Aseptic Processing guidelines for Controlled Environments.
  • 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 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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