Syner-G BioPharma Group logo
Syner-G BioPharma Group

To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire

Senior Project Manager

Project ManagerProject ManagerFull TimeRemoteSeniorTeam 201-500H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree10 yrs expEnglishAirflowPMP

Job Description

Senior Project Manager

Syner-G BioPharma Group

• 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

Job 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

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