Commissioning, Qualification and Validation (CQV)
Project Manager / Sr. Project Manager – Commissioning, Qualification and Validation (CQV)
Responsible for the overall project execution and project deliverables related to Commissioning, Qualification and Validation of pharmaceutical, biotech and AMTP facilities, laboratory and manufacturing equipment and processes. Responsibilities are expected to include but are not limited to:
• The Project Manager will be responsible for developing project scope statements, estimates and staffing plans.
• Project Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.
• Train and mentor newer validation engineers.
• Minimum of 10 years experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Strong organizational skills, excellent writing and communications skills.
• Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
• Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches and tools for compliance are desired.
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Diverse experience in leading project teams related to the commissioning and qualification of clean/dirty utilities, HVAC, facility systems, process support systems, and process equipment.
• Willing and able to travel as necessary for project requirements to include but not be limited to: Factory Acceptance Testing, project installation and start-up activities, client meetings, company sponsored meetings, etc.
• Ability to be a part of the field execution team.
• Proficiency with Microsoft Office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
• BS Degree in Engineering/ STEM discipline or related technical degree.