Sr. Project Manager
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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
- QUA
Additional Information
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com 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.
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