CQV Project Manager

4 weeks ago


Princeton, United States Azzur Group Full time
Description

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

Experience:

*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

Education:

*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
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