Job Details
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