POSITION OVERVIEW:
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. The ideal candidate will have extensive experience managing cross functional teams, driving HVAC and cleanroom projects, and ensuring alignment with organizational goals, regulatory expectations, and client requirements. This role requires strong leadership, deep understanding of HVAC systems, cleanroom environments, and CQV processes, and the ability to manage multiple high visibility workstreams from planning through execution and closeout.

WORK LOCATION:
Travel to client sites may be required up to 100%, depending on project needs and client expectations.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented or adjusted as needed.)

• 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
• Coordinate 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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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)
• Strong experience with HVAC systems, cleanroom environments, and facility utilities (e.g., chilled water, steam, controls)
• Experience leading HVAC-focused projects and managing multiple concurrent initiatives
• Experience with CQV lifecycle activities including commissioning and qualification of HVAC systems
• Experience with cleanroom standards, environmental monitoring, and contamination control principles
• Experience conducting or overseeing field walkdowns, readiness checks, and operational verification
• Familiarity with BMS/EMS systems and HVAC control strategies
• Experience with GMP documentation, change control, deviations, and validation packages
• Familiarity with CMMS, eQMS, LMS, or similar regulated systems
• 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
• Deep knowledge of commissioning, qualification, and facility readiness processes
• Exceptional leadership, organizational, and communication skills
• Ability to manage multiple complex workstreams and competing priorities in a fast paced environment
• Strong interpersonal skills with the ability to influence and collaborate across engineering, CQV, and operations teams
• Detail oriented with strong analytical and problem solving abilities, especially related to system performance and compliance
• Ability to work independently while providing direction and support to cross functional teams

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.