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Validation Engineer
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Location: West Conshohocken, PA
Salary: $75.00 USD Hourly - $100.00 USD Hourly
Description: Our client is currently seeking a Validation Engineer for a 12 month + contract.
As a Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning Project Manager, you'll join our collaborative team providing Commissioning and Start-Up services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position is client facing with an emphasis on ensuring Commissioning project deliverables meet schedule, cost, scope, quality, and safety. This position shall be responsible for the development of start-up and commissioning plans, commissioning documentation, and execution of these documents for a variety of facilities, utility systems, and equipment. This role serves a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.
We are looking for a passionate CQV Commissioning Project Manager who is driven by collaboration, exceeding expectations, and challenging the status quo. You'll be accountable for oversight, coordination, and execution of the start-up, energization, commissioning, and visual inspection of facilities, black and clean utility systems, HVAC, and production equipment.
You will also be responsible for the following duties:
Develop Project Start-Up and Commissioning Plan and execution strategies
Lead the team in Developing System Start-Up and Commissioning Plans for black utility and HVAC systems
Lead the team in Generating and executing Start-Up and Commissioning documents according to Good Documentation Practices (GDPs)
Startup equipment in a safe and effective manner
Facilitate meetings for the start-up Team
Maintain action item lists
Maintain engineering change control logs
Provide technical assistance and input
Coordination of OEM Service technicians as needed
Coordination with construction management firm as needed
Apply engineering knowledge of, and experience with, HVAC, black utilities, instrumentation, controls, and automation to support clients
Qualifications:
BS in Mechanical, Electrical or Chemical Engineering or equivalent years of experience in lieu of degree
5-14 years of Start-Up and Commissioning experience in the life sciences industry. Black utilities and HVAC start-up experience required
Understanding of Good Manufacturing Practices (GMPs)
Understanding of Good Documentation Practices (GDPs)
Proficient with Microsoft Office - Word, Excel
Flexibility and willingness to travel and work at various clients' locations
Ability to work well with diverse, multi-disciplined groups
Ability to effectively communicate with management and fellow project team members
Ability to negotiate/compromise with other project team members to achieve project goal
Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements
Ideally, you'll also have:
Proposal development experience
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Six Sigma Certification
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $75.00 USD Hourly - $100.00 USD Hourly
Description: Our client is currently seeking a Validation Engineer for a 12 month + contract.
As a Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning Project Manager, you'll join our collaborative team providing Commissioning and Start-Up services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position is client facing with an emphasis on ensuring Commissioning project deliverables meet schedule, cost, scope, quality, and safety. This position shall be responsible for the development of start-up and commissioning plans, commissioning documentation, and execution of these documents for a variety of facilities, utility systems, and equipment. This role serves a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.
We are looking for a passionate CQV Commissioning Project Manager who is driven by collaboration, exceeding expectations, and challenging the status quo. You'll be accountable for oversight, coordination, and execution of the start-up, energization, commissioning, and visual inspection of facilities, black and clean utility systems, HVAC, and production equipment.
You will also be responsible for the following duties:
Develop Project Start-Up and Commissioning Plan and execution strategies
Lead the team in Developing System Start-Up and Commissioning Plans for black utility and HVAC systems
Lead the team in Generating and executing Start-Up and Commissioning documents according to Good Documentation Practices (GDPs)
Startup equipment in a safe and effective manner
Facilitate meetings for the start-up Team
Maintain action item lists
Maintain engineering change control logs
Provide technical assistance and input
Coordination of OEM Service technicians as needed
Coordination with construction management firm as needed
Apply engineering knowledge of, and experience with, HVAC, black utilities, instrumentation, controls, and automation to support clients
Qualifications:
BS in Mechanical, Electrical or Chemical Engineering or equivalent years of experience in lieu of degree
5-14 years of Start-Up and Commissioning experience in the life sciences industry. Black utilities and HVAC start-up experience required
Understanding of Good Manufacturing Practices (GMPs)
Understanding of Good Documentation Practices (GDPs)
Proficient with Microsoft Office - Word, Excel
Flexibility and willingness to travel and work at various clients' locations
Ability to work well with diverse, multi-disciplined groups
Ability to effectively communicate with management and fellow project team members
Ability to negotiate/compromise with other project team members to achieve project goal
Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements
Ideally, you'll also have:
Proposal development experience
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Six Sigma Certification
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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