Senior Commissioning & Qualification (C&Q) Lead (a), 100%

Das ist der Job

ppTo drive our continuous organic growth, we are constantly looking for highly qualified professionals.

Darum lohnt es sich

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.

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 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.