CQV Project Manager

CQV Project Manager

Location: Princeton, NJ

Department: Azzur Consulting LLC

Job 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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