Browse by job sector

Verification Lead

  1. North America, United States
Michigan
  1. Contract
Competitive
  1. CAPEX Projects
33495
Apply to this job Save job
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
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Technical Services Specialist

Salary

Competitive

Location

Athlone

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Midlands (Ireland)

Description

Technical Services Specialist - Athlone - 12-Month Contract  Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation?

Reference

35728

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more
Mechanical Engineer

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Denmark

Description

Mechanical Engineer   - Denmark - 12 Months Contract   Our client, a global health care company that specialises in diabetes care, are looking for a Mechanical Engineer  to join their team.

Reference

36462

Expiry Date

01/01/0001

Alex Stanford

Author

Alex Stanford
Alex Stanford

Author

Alex Stanford
Read more
Read more
Project Engineer

Salary

Competitive

Location

Ohio

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Project Engineer - Ohio, United States - 12 Months Contract This is a fantastic opportunity for a Project Engineer to join our major, global pharmaceutical client on their latest new-build project

Reference

36455

Expiry Date

01/01/0001

Kristen Scott

Author

Kristen Scott
Kristen Scott

Author

Kristen Scott
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