Program Manager, Ops & Engineering

We are seeking a proactive and detail-oriented Program Manager to help lead cross-

functional execution of sterile and non-sterile compounding initiatives within our 503A and

503B facilities. This role is critical in ensuring project delivery across capital buildouts,

equipment installs, tech transfers, and process improvements, all while maintaining

compliance and operational efficiency. The ideal candidate will bring a strong background

in project/program management within GMP-regulated environments and will serve as the

central point of coordination across engineering, quality, operations, and external vendors.

You Will:

Program & Project Management

• Support and coordinate planning and execution of tasks within capital and operational

  programs in sterile and non-sterile compounding environments, in partnership with the lead engineer.

• Track integrated project plans, including timelines, milestones, risk mitigation actions,

  and deliverables.

• Maintain up-to-date visibility into budgets, spend forecasts, change logs, and schedule

  deviations; escalate concerns early.

• Ensure timely follow-up and closure of assigned tasks across cross-functional teams.

Cross-Functional Execution

• Drive collaboration between engineering, validation, quality, pharmacy, and manufacturing teams to align resources and resolve blockers.
• Facilitate weekly syncs, issue logs, and decision-making frameworks to ensure timely

  project delivery.

• Serve as liaison to external consultants, vendors, and contractors during equipment

  selection, installation, and qualification.

Compliance & Documentation

• Ensure programs comply with cGMP, USP 795 & 797 & 800 and applicable FDA

  requirements.

• Track and manage change controls, deviations, and CAPAs related to capital projects

  and operational launches.

• Support audit readiness by ensuring accurate documentation, traceability, and

  resolution of program risks.

Facility & Equipment Enablement

• Oversee execution of cleanroom and process suite buildouts for sterile and non-sterile

  compounding.

• Coordinate readiness for equipment FATs, SATs, and site commissioning.
• Partner with validation and engineering teams for timely completion of IQ/OQ/PQ.

Communication & Reporting

• Prepare and deliver concise program status reports to senior leadership.
• Maintain dashboards, Gantt charts, risk registers, and other program governance tools.
• Communicate across stakeholders with clarity and urgency to manage changing

  priorities and constraints.

You Have:

• Bachelor’s degree in Engineering, Project Management, or a related technical discipline.
• 5+ years of experience managing cross-functional projects or programs in GMP

  pharmaceutical manufacturing (sterile and non-sterile).

• Proven success in managing capital projects, equipment installations, and product

  launches within 503A/503B or CDMO environments.

• Strong understanding of sterile compounding workflows, cleanroom classifications, and

  aseptic processing best practices.

• Working knowledge of USP 795, 797 & 800, cGMP, 21 CFR Part 210/211, and

  validation lifecycle documentation.

• Excellent organizational and problem-solving skills; ability to manage multiple

  concurrent initiatives and conflicting priorities.

• Proficiency in project management tools such as Smartsheet, MS Project etc. to produce

  Gantt charts and action trackers for concurrent projects

• Strong written and verbal communication skills; ability to influence cross-functional

  teams and drive accountability.

• Ability to gather and document requirements, track comments and get approvals from

  different stakeholders to maintain accountability

Nice to have:

• PMP certification or equivalent.
• Experience with cleanroom facility buildouts, environmental monitoring systems, and

  process utility commissioning.

• Familiarity with pharmacy operations, hazardous drug handling, or compounding

  regulatory frameworks.

• Willingness to travel as needed to other sites in the US to support execution and

  oversight. Up to 30%

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats