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.
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CQ Project Manager Arbeitgeber: EFOR
Als Arbeitgeber in der biopharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und kontinuierliche Verbesserung setzt. Unsere Unternehmenskultur fördert nicht nur die persönliche und berufliche Weiterentwicklung, sondern bietet auch attraktive Benefits wie flexible Arbeitszeiten und ein unterstützendes Arbeitsumfeld. In der Region Rheinland-Pfalz profitieren Sie von einer hervorragenden Lebensqualität und einer starken Gemeinschaft, die Ihre Karriere im Bereich Clean Utilities vorantreibt.
