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Senior commissioning & qualification (c&q) lead (a), 100%

Bubendorf
Bachem AG
Inserat online seit: 12 Juni
Beschreibung

PpTo drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the Global Engineering department, we are looking for a dedicated Senior Commissioning Qualification (CQ) Lead (f/m/d), 100%. /p pIn this role, you are responsible for the strategic planning, execution, and oversight of commissioning, qualification, and validation activities for GMP-regulated pharmaceutical facilities. Furthermore, this role ensures that all systems, equipment, and utilities are delivered in full compliance with regulatory requirements, quality standards, and project timelines. Acting as a technical and regulatory leader, the position interfaces closely with Engineering, Quality, Automation, Operations, and external partners throughout the project lifecycle. /p h3Responsibilities /h3 ul liLead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems /li liDevelop and implement CQ strategies, CQ Master Plans, and risk-based qualification approaches /li liAuthor, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports /li liEnsure compliance with GMP regulations and internal quality standards /li liAct as the primary CQ interface to Quality Assurance and support regulatory inspections and audits /li liCoordinate cross-functional stakeholders and manage external vendors and CQV consultants /li liMonitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership /li liDrive standardization, continuous improvement, and best practices across CQ activities /li /ul h3Qualifications /h3 ul liBachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline /li liExtensive experience in Commissioning Qualification / Validation within the pharmaceutical industry /li liProven track record of leading CQ activities on large scale GMP capital projects /li liStrong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologies /li liExperience with facilities and utilities (e.g. HVAC, media systems); automation and CSV experience is an advantage /li liExcellent written and spoken German and English /li /ul h3Benefits /h3 ul liA dynamic and rapidly growing work environment with internal development and training opportunities /li liFlexible working hours with home office days and an option for obtaining additional vacation days through workload reduction /li liCompany‑run daycare center on the Bachem Campus in Bubendorf /li li60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus /li liAccess to benefits platforms with discounts from external partners /li liFresh, healthy and varied food in our staff restaurant /li liA wide range of free sports activities on the Bachem Campus /li /ul pWould you like to drive innovation together with us? /p pWe look forward to receiving your complete application documents via our application portal. /p pLearn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf! /p /p #J-18808-Ljbffr

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