Senior Project Manager

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• 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

🎯 Requirements

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical field. A Master’s degree or PMP certification is a plus. • 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.

🏖️ Benefits

• market competitive base salary and annual incentive plan • robust benefit offerings • ongoing recognition and career development opportunities • generous flexible paid time off program • company-paid holidays • flexible working hours • fully remote work options for most positions