Sr. Project Manager

About the role

We are seeking a Sr. Manager with 10-15 years of experience to lead and oversee complex HVAC, facility, and validation-focused initiatives within GMP regulated life sciences environments.

Responsibilities

• Provide strategic leadership and oversight for projects spanning HVAC systems, facility infrastructure, commissioning, qualification, and operational readiness
• Lead HVAC project execution activities across pharmaceutical manufacturing, laboratory, and support areas
• Develop and manage project plans, schedules, budgets, resource strategies, and risk mitigation activities across multiple workstreams
• Cook up HVAC scope with construction, CQV, automation, facilities, and manufacturing teams
• Oversee cleanroom implementation including airflow design, pressurization cascades, and environmental control strategies to meet GMP requirements
• Manage contractors, vendors, schedules, field execution, and punch list activities through project completion
• Drive HVAC startup, commissioning, qualification (IQ/OQ/PQ), and validation activities in alignment with CQV strategies
• Support cleanroom and GMP facility readiness activities, including environmental monitoring alignment and operational setup
• Perform and lead field walkdowns, system inspections, and issue resolution for HVAC and facility systems
• Ensure delivery of key milestones, commissioning deliverables, validation packages, and turnover documentation
• Guide development and execution of commissioning plans, qualification protocols, and turnover packages
• Partner with CQV teams to ensure design and user requirements translate effectively into validation documentation and execution
• Ensure alignment with engineering standards, safety requirements, and GMP expectations
• Identify risks and drive mitigation strategies related to HVAC performance, contamination control, and facility operations
• Track project deliverables, budgets, timelines, KPIs, and action items across all workstreams
• Facilitate cross-functional meetings and communicate project status to leadership and stakeholders
• Coordinate change controls, deviations, CAPAs, and documentation within quality systems (eQMS)
• Support operational readiness and transition from construction and CQV into facility operations
• Utilize systems such as CMMS, eQMS, LMS, and digital validation platforms; experience with KNEAT is a plus
• Mentor and support project managers, engineers, and coordinators to ensure high quality execution and professional development

Qualifications And Requirements

• Education: Bachelor’s Degree in Engineering, Life Sciences, or a related technical field. A Master’s degree or PMP certification is a plus.
• Technical Experience: 10–15 years of experience in GMP regulated environments (biotech, pharmaceutical, cell/gene therapy, or medical device)
• Experience: Strong experience with HVAC systems, cleanroom environments, and facility utilities (e.g., chilled water, steam, controls)
• Experience: Experience leading HVAC-focused projects and managing multiple concurrent initiatives
• Experience: Experience with CQV lifecycle activities including commissioning and qualification of HVAC systems
• Experience: Experience with cleanroom standards, environmental monitoring, and contamination control principles
• Experience: Familiarity with BMS/EMS systems and HVAC control strategies
• Experience: Experience with GMP documentation, change control, deviations, and validation packages
• Experience: Familiarity with CMMS, eQMS, LMS, or similar regulated systems
• Experience: Experience with KNEAT or digital validation platforms is a plus
• Knowledge, Skills, And Abilities: Strong understanding of HVAC systems, airflow dynamics, and cleanroom design within GMP environments
• Knowledge, Skills, And Abilities: Deep knowledge of commissioning, qualification, and facility readiness processes
• Knowledge, Skills, And Abilities: Exceptional leadership, organizational, and communication skills
• Knowledge, Skills, And Abilities: Ability to manage multiple complex workstreams and competing priorities in a fast paced environment
• Knowledge, Skills, And Abilities: Strong interpersonal skills with the ability to influence and collaborate across engineering, CQV, and operations teams
• Knowledge, Skills, And Abilities: Detail oriented with strong analytical and problem solving abilities, especially related to system performance and compliance
• Physical Demands: The physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.