C&Q Program Lead

C&Q Program Lead Engagement Details

• Location: Lebanon, Indiana — 100% On-site, 5 days/week
• Duration: 12 months with anticipated extensions
• Start Date: ASAP
• Schedule: 40hrs/week standard; 10+ hours OT typical
• Reporting Line: Executive Director, Program Commissioning & Qualification
• Interviews: ASAP
• Pay Rate: $150-170/hr 1099/C2C | $135-150/hr W2

Planet Pharma is partnering with a large-scale pharmaceutical API manufacturing capital program in Lebanon, IN to identify a C&Q Program Lead for a Utilities Building and Tank Farm / Solvent Recovery systems. This is a single-point-of-accountability leadership role — the owner’s direct on-site representative for all commissioning and qualification activities across critical site utility and solvent infrastructure.

This is not a protocol execution role. The right candidate owns the strategy, drives the execution contractor, manages the schedule and risk register, and delivers CUB and TFSR systems in a GMP-compliant, inspection-ready state through to operational handover. If you’ve led C&Q programs end-to-end on pharmaceutical or API capital programs and can operate with authority across construction, engineering, quality, and operations stakeholders — this role was built for you.

CUB — Clean and black utility generation and distribution including WFI, clean steam, purified water, process and lab gases, HVAC, chilled water, plant steam, compressed and instrument air, and associated electrical systems.

TFSR — Bulk raw material and solvent storage, distribution, and solvent recovery and distillation systems — including associated safety and environmental controls.

• Serve as the direct on-site owner’s representative — leading multiple CQV teams from documentation preparation through FAT, CM oversight, integrated C&Q execution, PQ/PPQ support, and successful handover to the Client/User team
• Own the C&Q strategy and execution plan for CUB and TFSR — aligned to site quality, safety, and project objectives
• Define system boundaries, risk-based C&Q approach (GEP / ASTM E2500), and acceptance criteria
• Develop the overall CQV documentation plan in conjunction with the project scheduler and C&Q execution contractors
• Lead weekly multidisciplinary CQV, Engineering, Construction Management, and User coordination meetings
• Serve as the primary C&Q interface to the Project Leadership Team, GFD Functional Teams, and Site Operations

• Direct and oversee the C&Q execution contractor — managing scope, deliverables, and performance
• Review and approve commissioning and qualification protocols and reports (IV/OQ/PQ as applicable)
• Define workflows and approval cycles for CQV test plans and specifications
• Manage the commercial basis for C&Q contracts — SOW, resourcing, T&M basis, and change control

• Own CQV schedule milestones — anchoring and maintaining key dates including MC end, IV start, and SSU
• Maintain the C&Q risk register for CUB and TFSR scope — escalating constraints and driving mitigation across construction, C&Q, and startup teams
• Proactively identify and resolve issues impacting C&Q readiness, system acceptance, and operational handover

• Manage mechanical completion handover from the EPC and construction partner — including turnover packages and system walkdowns
• Ensure C&Q documentation is complete, accurate, and inspection-ready — turnover manuals, field checklists, and roll-up reporting
• Close gaps between construction turnover documentation and C&Q checklist and standards requirements

• Ensure all C&Q activities meet GMP, GEP, and applicable quality standards — maintaining audit and inspection readiness throughout
• Support deviation management, punch list resolution, and change management through to system acceptance

• Develop the C&Q organization chart and lead resourcing reviews — benchmarking against reference sites
• Track and forecast C&Q cost and staffing — supporting budget and contract decisions

• Bachelor’s degree in Chemical, Mechanical, or related Engineering discipline — or equivalent
• 10+ years…