Inserat online seit: 10 Juni
Aufgaben der Stelle
Pul liBachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see /li liTo 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% /li liIn 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 /li liAct as the primary CQ interface to Quality Assurance and support regulatory inspections and audits, functional stakeholders, and manage external vendors and CQV consultants. /li /ul h3Your tasks: /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, 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 h3Your profile: /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 h3Our offer: /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 li60% coverage of pension fund contributions by Bachem AG as well as an 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 pWe welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. /p /p #J-18808-Ljbffr
