VALIDATION ENGINEER

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 goals

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