POSITION OVERVIEW:

We are seeking a Sr. Manager with 10-15 years of experience to lead and oversee complex Commissioning, Qualification, Validation (CQV), HVAC, facility, utility, and operational readiness initiatives within GMP-regulated life sciences environments. The ideal candidate will have extensive experience managing cross-functional teams, driving commissioning and qualification programs for pharmaceutical manufacturing facilities, cleanrooms, utilities, and support systems, and ensuring alignment with organizational goals, regulatory expectations, and client requirements. This role requires strong leadership, deep technical expertise in HVAC systems, cleanroom environments, facility utilities, and risk-based CQV methodologies, as well as the ability to manage multiple high-visibility workstreams from planning through execution, turnover, and operational readiness. The successful candidate will serve as a key leader in coordinating construction, engineering, automation, validation, quality, and operations teams to deliver compliant and efficient project execution.

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, validation, startup, and operational readiness.
• Lead overall C&Q execution strategy for assigned manufacturing areas, utilities, cleanrooms, HVAC systems, and support systems within GMP-regulated facilities.
• Manage commissioning, qualification, validation, startup, and turnover activities from construction completion through operational readiness and handoff to operations.
• Lead HVAC project execution activities across pharmaceutical manufacturing, laboratory, utility, and support areas.
• Coordinate daily activities of CQV engineers, contractors, vendors, and third-party service providers to ensure successful project execution.
• Develop and maintain integrated C&Q schedules aligned with construction, automation, startup, and manufacturing readiness milestones.
• Develop and manage project plans, schedules, budgets, resource strategies, and risk mitigation activities across multiple workstreams.
• Coordinate HVAC, facility, utility, and CQV scope with construction, automation, facilities, manufacturing, quality, and engineering teams.
• Facilitate and lead system impact assessments, criticality assessments, boundary reviews, and turnover planning activities.
• Oversee cleanroom implementation including airflow design, pressurization cascades, environmental controls, and contamination control strategies to meet GMP requirements.
• Manage contractors, vendors, schedules, field execution activities, startup efforts, and punch list resolution through project completion.
• Drive HVAC startup, commissioning, qualification (IQ/OQ/PQ), validation, and operational readiness activities in alignment with project CQV strategies.
• Support Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), vendor startup activities, integrated system testing, and system readiness verification.
• Perform and lead field walkdowns, system inspections, field verification activities, and issue resolution for manufacturing, utility, HVAC, and facility systems.
• Review and approve commissioning and qualification documentation including Commissioning Plans, Commissioning Test Plans (CTPs), Commissioning Test Records, IQ/OQ/PQ Protocols, Summary Reports, Turnover Packages, ETOP Documentation, and associated startup documentation.
• Ensure delivery of key milestones, commissioning deliverables, validation packages, and turnover documentation.
• Guide development and execution of commissioning plans, qualification protocols, validation strategies, and turnover packages.
• Partner with Quality, Validation, Engineering, and Operations organizations to ensure compliance with corporate standards, GMP requirements, and regulatory expectations.
• Support risk assessments, change controls, deviations, CAPAs, investigations, and readiness reviews.
• Drive issue resolution, action item management, and punch list closure to support timely qualification and system release.
• Ensure consistent application of risk-based CQV methodologies across all assigned systems and projects.
• Support cleanroom and GMP facility readiness activities, including environmental monitoring alignment, operational setup, and manufacturing startup.
• Partner with CQV teams to ensure design intent and user requirements are effectively translated into testing, qualification, and validation documentation.
• Ensure alignment with engineering standards, safety requirements, commissioning objectives, and GMP expectations.
• Identify risks and drive mitigation strategies related to system performance, contamination control, operational readiness, compliance, and facility operations.
• Track project deliverables, budgets, schedules, KPIs, timelines, and action items across all workstreams.
• Develop and provide status updates, KPI reporting, dashboards, and executive-level communications to project stakeholders and leadership teams.
• Facilitate cross-functional meetings and communicate project status, risks, mitigation plans, and readiness activities to leadership and stakeholders.
• Coordinate change controls, deviations, CAPAs, investigations, and documentation activities within quality management systems (eQMS).
• Support operational readiness programs and transition activities from construction and CQV into facility operations and manufacturing.
• Utilize systems such as CMMS, eQMS, LMS, and digital validation platforms; experience with Kneat is preferred.
• Promote a strong safety culture and ensure compliance with all site safety requirements, policies, and procedures.
• Mentor and support project managers, CQV engineers, validation specialists, 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, PMP certification, or equivalent project management credential is a plus.

Technical Experience

• 10–15 years of experience in GMP-regulated environments (biotech, pharmaceutical, small molecule, cell and gene therapy, biologics, or medical device).
• Significant experience leading commissioning, qualification, validation, and operational readiness activities for manufacturing facilities, utilities, HVAC systems, cleanrooms, and support systems.
• Strong experience with HVAC systems, cleanroom environments, and facility utilities (e.g., chilled water, steam, compressed gases, WFI, clean utilities, controls, and automation systems).
• Experience leading large-scale CQV programs and managing multiple concurrent projects through startup and turnover.
• Demonstrated experience with commissioning and qualification lifecycle activities, including system impact assessments, criticality assessments, protocol development, test execution, and final release.
• Experience supporting FATs, SATs, integrated system testing, startup activities, and operational readiness programs.
• Experience with cleanroom standards, environmental monitoring programs, and contamination control principles.
• Experience conducting and leading field walkdowns, readiness assessments, turnover activities, and operational verification.
• Familiarity with BMS, EMS, DCS, SCADA, and HVAC control strategies.
• Experience with GMP documentation, change control, deviations, investigations, CAPAs, and validation packages.
• Familiarity with CMMS, eQMS, LMS, and other regulated systems.
• Experience with Kneat or other digital validation platforms is preferred.

Knowledge, Skills, and Abilities

• Strong understanding of HVAC systems, facility utilities, airflow dynamics, cleanroom design, and contamination control within GMP environments.
• Deep knowledge of commissioning, qualification, validation, startup, turnover, and operational readiness processes.
• Demonstrated expertise in risk-based CQV methodologies and regulatory compliance requirements.
• Exceptional leadership, organizational, project management, 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, Construction, CQV, Quality, Validation, Manufacturing, and Operations teams.
• Detail-oriented with strong analytical and problem-solving abilities, especially related to system performance, qualification, compliance, and startup challenges.
• Ability to work independently while providing direction and support to cross-functional teams and project stakeholders.
• Strong presentation skills with experience delivering executive-level updates, KPI reporting, and project status communications.
• Ability to build and maintain productive relationships with clients, vendors, contractors, and internal stakeholders.