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