Validation Engineering Professional Senior

Job Title: Validation Engineering Professional Senior

Duration: 14+ Months

Location: Conshohocken, PA 19428

Responsibilities:

As a commissioning, qualification, and validation (CQV) start-up/commissioning project manager, you'll join our collaborative team that provides 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 Plans and execution strategies.

Lead the team in Developing System Start-Up and Commissioning Plans for black utility and HVAC systems.

Led 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 are 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:

• ISPE Baseline Guide 5 Commissioning and Qualification.
• ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems.
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
• ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011.
• ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011.
• Six Sigma Certification.