CQ Planner - CAPEX Project

Location:

On-site at Lehigh Valley, PA (First 2 months remote, then On-site)

Company: EFOR

Client:
Eli Lilly

Employment Type:

Full-Time / Contractor

Salary Range:
Depending on experience and qualifications

EFOR is seeking a Commissioning & Qualification (CQ) Planner to support a major CAPEX project for Eli Lilly, a leading biopharmaceutical manufacturing organization.

The CQ Planner will partner with Engineering, Commissioning, Quality, Validation, Project Management, and Operations teams to plan, coordinate, and execute commissioning and qualification activities (IQ, OQ, PQ) in compliance with cGMP and regulatory standards.

The ideal candidate has significant experience managing CAPEX projects in regulated pharmaceutical environments and is proficient in Primavera P6 for project planning and scheduling. The role offers a hybrid arrangement: 2 months remote, then on-site presence for direct oversight of commissioning and qualification execution.

• Develop and maintain detailed CAPEX project schedules using Primavera P6, with focus on Commissioning & Qualification (CQ) phases
• Plan and coordinate IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) activities integrated into the overall project timeline
• Work with Engineering, Commissioning Leads, Quality, and Operations teams to identify critical CQ milestones and deliverables
• Support planning and scheduling of equipment commissioning, FAT (Factory Acceptance Testing), and SAT (Site Acceptance Testing)
• Coordinate regulatory compliance requirements (FDA 21 CFR Part 11, cGMP, ICH) for CQ documentation and activities
• Manage dependencies between engineering installation, commissioning, qualification, and production readiness work streams
• Track and report project progress and CQ phase status via P6 with KPIs and dashboards
• Coordinate CQ status meetings and milestone reviews with multidisciplinary stakeholders
• Support development and management of CQ protocols, test reports, and validation documentation
• Identify and mitigate schedule risks and compliance issues related to commissioning and qualification
• Participate in continuous-improvement initiatives related to CQ execution and project planning

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Project Management, or related discipline
• 8+ years of experience managing CAPEX projects in a regulated pharmaceutical, biopharmaceutical, or medical device environment
• Proven proficiency in Primavera P6 (P6 Standard or Professional) – scheduling, tracking, and reporting
• Strong experience in Commissioning & Qualification (IQ/OQ/PQ) planning and execution
• Working knowledge of cGMP, FDA regulations, and Good Documentation Practices
• Experience managing complex equipment commissioning and qualification in manufacturing facilities
• Excellent written and verbal communication skills
• Ability to work effectively in a matrix environment with multiple stakeholders
• Strong organizational skills and ability to manage competing priorities and complex schedules

• Experience managing CAPEX projects for new production lines or facility expansion
• Experience with FAT/SAT (Factory/Site Acceptance Testing) coordination
• Project Management Professional (PMP) certification or equivalent
• Experience with risk management tools (FMEA, risk registers)
• Experience with pharmaceutical manufacturing systems, utilities, HVAC, or facility operations
• Familiarity with Veeva Vault or similar validation document systems

• Remote: 2 months (with regular virtual meetings and stakeholder coordination)
• On-site: Remainder of project duration for direct commissioning and qualification oversight
• Location: Lehigh Valley, PA

EFOR offers a competitive benefits package, including:

• 20 days of Paid Time Off
• 9 paid company holidays
• Medical insurance
• Vision insurance
• Employer-sponsored insurance and benefits programs
• Professional development and career-growth opportunities
• Exposure to major pharmaceutical and biotechnology manufacturing programs

EFOR provides engineering, consulting, and project-delivery expertise to leading pharmaceutical and biotechnology organizations. Our teams support clients across Project Management, Engineering, Commissioning & Qualification, Validation, Facilities, Quality, and other specialized domains, providing both strategic and operational support throughout the lifecycle of regulated manufacturing projects.