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!