CQV Project Manager

Consulting Princeton, New Jersey


Essential Duties and Responsibilities:  
*Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means 
*Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) 
*Successfully validate, qualify, or requalify laboratory and / or manufacturing equipment in a regulated GMP environment 
*Perform (hands on) field execution of commissioning and/or validation documentation 
*Provide ongoing communication to clients and build client relationships through this process 
* Accountable for core team performance, project schedule and execution, and budget commitments 
* Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified 
* Ensures identification and communication of project risks, development of risk plan and leads core team in the proactive management of risk response strategies 
* Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes  
*Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders  
*Actively participate in the mentoring, training of junior engineers and development 
*10 years previous experience with successful validation, qualification, or requalification of laboratory and / or manufacturing equipment in a regulated GMP environment, including 5 years project management experience with demonstrated success leading projects 
*Minimum of a Bachelor’s of Science in Engineering or Science degree or equivalent discipline required 
*MS Project required 
*PMP certification is desired  
*PMI or IPMA or equivalent certification desired