System Owner – Synthesis

Location: Lebanon, Indiana – On-site 4 days/week

About the Role

Planet Pharma is partnering with a large-scale pharmaceutical API manufacturing capital program in Lebanon, IN to identify a System Owner – Synthesis. This is an owner's representative role embedded within the project team, serving as the single point of contact for all Synthesis process systems — including reactors, vessels, centrifuges, dryers, process transfer piping, and associated utility tie-ins — from construction through mechanical completion, commissioning and qualification (C&Q), and final handover to Operations. This is not a design role. The right candidate brings system-level coordination discipline, working knowledge of API/Drug Substance process equipment, and the organizational credibility to keep complex, multi-discipline synthesis systems on track across a fast-moving capital program.

On a program of this scale and complexity, Synthesis systems don't run themselves to completion — someone has to own them. This role is that owner. You will be the go-to authority on where every reactor, vessel, centrifuge, dryer, and utility tie-in stands at any given moment — what's installed, what's punched, what's at risk, and what needs to move. You'll work across process, mechanical, automation, utilities, and C&Q disciplines to keep systems complete, fit for purpose, and ready for safe operation. If you thrive in a coordination and ownership role where your organizational discipline and stakeholder management directly impact program outcomes, this is your seat.

Responsibilities

Construction, Mechanical Completion & C&Q

• Serve as the single point of contact for all Synthesis system queries covering construction status, installation, and readiness — including process reactors, vessels, centrifuges, dryers, transfer piping, and utility tie-ins (WFI, nitrogen, steam, chilled water)
• Monitor installation progress across Synthesis process equipment and piping — confirming systems align with approved requirements and escalating discrepancies
• Review field changes and as-built updates for Synthesis systems, escalating design-related matters through the appropriate engineering channel
• Monitor construction practices and equipment preservation for Synthesis process equipment prior to startup
• Participate in walkdowns and system turnover from Mechanical Completion through C&Q to Operations handover
• Coordinate interfaces between Synthesis systems and other disciplines including CSA, MEP, automation/controls, and utilities
• Identify and track Synthesis punch list items through to closure

Technical Coordination

• Provide operational and installation input to support the C&Q program for Synthesis systems
• Coordinate with C&Q Lead on Synthesis readiness, turnover documentation, and punch list closure
• Raise design-related queries through the appropriate engineering lead
• Support System Start-Up Readiness activities post-handover for Synthesis systems where required

Schedule & Progress Monitoring

• Provide Synthesis system-level inputs into the integrated project schedule
• Participate in look-ahead and pull-planning sessions for Synthesis equipment and piping installation sequencing
• Monitor progress and identify risks to system readiness — including long-lead reactor and vessel deliveries and skid fabrication delays
• Escalate schedule deviations and support mitigation planning

Change & Risk Management

• Identify and raise Synthesis field changes through formal change management processes
• Proactively identify and manage system-level risks including process equipment compatibility, utility capacity conflicts, and batch record alignment
• Ensure mitigation actions are defined, tracked, and escalated where required

Issue Resolution & Reporting

• Coordinate resolution of Synthesis construction, installation, and readiness issues across disciplines
• Support closure of NCRs related to Synthesis systems
• Facilitate resolution of Synthesis field queries and escalate design matters appropriately
• Provide clear, consistent Synthesis system status updates to support project decision-making

Requirements

• 10+ years of experience in pharmaceutical, biotech, or API/Drug Substance manufacturing capital programs — with direct exposure to Synthesis or process equipment systems (reactors, vessels, centrifuges, dryers)
• Strong system-level coordination and organizational skills — you've owned scope, tracked it, and driven it to completion
• Solid understanding of construction, Mechanical Completion, and C&Q processes for Synthesis or Drug Substance manufacturing systems
• Effective communicator and influencer across process, mechanical, automation, and commissioning disciplines
• Familiarity with GMP requirements and cGMP synthesis suite construction practices
• Ability to identify risks proactively and drive issue resolution across complex multi-discipline environments
• Strong planning and schedule awareness — particularly around long-lead process equipment and utility coordination
• Collaborative mindset with the ability to operate across multidisciplinary teams without direct authority

Nice to Have

• Direct experience on large-scale greenfield pharmaceutical API or Drug Substance manufacturing facility builds
• Familiarity with utility systems common to synthesis environments — WFI, nitrogen, steam, chilled water
• Background working alongside automation/controls and C&Q teams during construction and commissioning
• Experience with turnover documentation platforms (Procore, Bluebeam, or equivalent)

Schedule

Duration: 1 year with anticipated extensions (total project 3+ years)

Start Date: September 2026

40 hours/week standard; 10 hours OT typical

Travel: Minimal

Pay

W2: $85-100/hr | 1099: $115-125/hr