Browse by job sector

Verification Lead

  1. North America, United States
Michigan
  1. Contract
Competitive
  1. CAPEX Projects
33495

This vacancy has now expired

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! 

 #LI-MC1
Save as a job alert
List #1

Similar Jobs

Project Technical Manager

Salary

Competitive

Location

Singapore

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Singapore

Description

Project Technical Manager - Singapore - Permanent Contract  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is

Reference

37557

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Suraj Chauhan

Author

Suraj Chauhan
Read more
Read more
Senior PM Tech Transfer

Salary

Competitive

Location

Oslo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Norway

Description

Senior PM Tech Transfer - North of Oslo, Norway - 12 Months Contract We are recruiting for a rapidly growing CDMO located in North Oslo. Our client is seeking an exceptional Project Manager with

Reference

36748

Expiry Date

01/01/0001

Charlie Yearley

Author

Charlie Yearley
Charlie Yearley

Author

Charlie Yearley
Read more
Read more
Senior Construction Project Manager

Salary

Competitive

Location

Raleigh

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Senior Construction Project Manager - RTP, North Carolina - 12 Months Contract Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Senior Construction

Reference

36313

Expiry Date

01/01/0001

Davis Atkinson

Author

Davis Atkinson
Davis Atkinson

Author

Davis Atkinson
Read more
Read more

Insights

North Carolina

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Living and Working in Chicago

Read more

08/18/2023

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV