C&Q Program Lead

The Opportunity

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.

Scope Overview

• Own C&Q for two critical facility scopes: Central Utility Building (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.

• Tank Farm / Solvent Recovery (TFSR) — Bulk raw material and solvent storage, distribution, and solvent recovery and distillation systems — including associated safety and environmental controls.

What You'll Own

• 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

• Be the primary C&Q interface to the Project Leadership Team, GFD Functional Teams, and Site Operations C&Q Execution & Contractor Management

• 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

Schedule, Milestones & Risk

• Own CQV schedule milestones — anchoring and maintaining key dates including MC end, IV start, and SSUM

• 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

Construction Handover & Documentation

• 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

Quality & Compliance

• 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

Resourcing & Budget

• 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

What We're Looking For

• Bachelor's degree in Chemical, Mechanical, or related Engineering discipline — or equivalent

• 10+ years of experience in commissioning, qualification, and startup within pharmaceutical, API, or regulated manufacturing environments

• Minimum 10 years of experience in a lead capacity managing major capital construction programs valued between $500M and $2B — pharmaceutical, life sciences, or other highly regulated process industries preferred.

• Demonstrated experience leading C&Q programs on capital projects and managing execution contractors end-to-end

• Strong knowledge of risk-based C&Q methodologies — ASTM E2500 and GEP frameworks

• Direct experience with clean utilities — WFI, clean steam, purified water, HVAC — and/or bulk solvent storage, distribution, and recovery systems strongly preferred

• Deep understanding of C&Q documentation and turnover/handover processes — MC through IV/OQ/PQ

• Proven program leadership across multiple stakeholders including construction, engineering, quality, and operations

• Contractor and vendor management experience — commercial acumen and SOW/T&M contract management

• Strong schedule and risk management skills with structured problem-solving ability

• Clear, confident communicator with both technical teams and senior program leadership

Nice to Have

• Direct experience on large-scale greenfield pharmaceutical API or drug substance manufacturing capital programs

• Familiarity with Tank Farm, Solvent Recovery, or bulk chemical storage systems in a GMP-regulated environment

• Experience supporting FDA or regulatory agency inspections on pharmaceutical capital programs

• Background working within an EPCM or GC-led delivery model from the owner's C&Q governance side