Sr. Project Manager

About the role

At Syner-G, we are seeking a Senior 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.

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); strong experience with HVAC systems, cleanroom environments, and facility utilities; 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.