CQ Project Manager

The CQ Project Manager is responsible for leading commissioning and qualification (CQ) activities for pharmaceutical engineering projects, with a strong focus on aseptic/sterile filling line operations. The role ensures delivery of CQ projects aligned with GMP/GxP standards, regulatory requirements, and best practices within pharmaceutical manufacturing. The ideal candidate will have direct experience with filling lines (liquid or solid dose, sterile/aseptic processes), and will manage cross-functional teams, documentation, and project milestones.

Key Responsibilities:

• Lead and coordinate commissioning and qualification projects for pharmaceutical manufacturing equipment, utilities, and especially filling lines.
• Develop, review, and approve CQ protocols, plans, and reports for assets and processes, ensuring compliance with GMP, GxP, and regulatory standards.
• Oversee execution of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), particularly for filling/packaging equipment.
• Liaise with engineering, validation, QA/QC, manufacturing, and vendors to align CQ activities with project timelines and deliverables.
• Manage project schedules, milestones, and resources, ensuring timely completion and compliance with site and regulatory expectations.
• Troubleshoot issues during CQ execution; facilitate problem-solving and corrective actions for filling line-related challenges.
• Ensure all CQ documentation—including deviations, CAPAs, test records, and change controls—are accurate, complete, and audit-ready.
• Support and prepare for regulatory inspections and audits by presenting CQ documentation and project evidence.
• Lead risk assessments, FAT/SAT oversight, and technical reviews for new equipment, especially filling line systems.
• Coach/train project team members on CQ processes, regulatory requirements, and aseptic filling best practices.
• Drive continuous improvement in CQ methodology, documentation, and equipment reliability.
• Participate in project meetings, reporting status, risks, and progress to stakeholders and site management.

Required Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related), Pharmaceutical Technology, Life Sciences, or equivalent.
• Minimum 10 years’ experience in CQ project management or validation in a pharmaceutical manufacturing environment.
• Direct experience commissioning and qualifying aseptic/sterile filling lines (liquid, vial, syringe, oral solid dose, or similar).
• Strong understanding of GMP/GxP, FDA/EMA/MHRA regulatory requirements, and pharmaceutical equipment CQ.
• Proven ability to lead cross-functional teams, manage project timelines, and deliver results.
• Excellent documentation, communication, and organizational skills.