Classified Environments Verification Lead - QCS Staffing : Job Details

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!