Senior Operations Process Specialist

ph3Senior Operations Process Specialist (m/f) /h3 pThe Senior Operations Specialist supports the CMT Operations organization and the Facility Start‑Up Manager. The role is responsible for executing non‑conformity (NC) and NC/CAPA processes and for supporting F2P2 Next Level start‑up activities. It also provides operational support for new technology implementations, continuous improvement initiatives, and product‑portfolio projects to enable compliant, scalable clinical manufacturing operations. /p h3Main Responsibilities /h3 ul liLead investigations into non‑conformities, drive corrective and preventive actions (CAPAs), and verify closure in collaboration with Quality. /li liProvide operational and technical input and hands‑on assistance for commissioning, qualification, and GMP‑compliant operations. /li liSupport technical assessments and pilot testing, contribute to process validation and SOP/work‑instruction development, and help ensure readiness for transfer to operations. /li liCollaborate with Quality, Engineering, Project Management and other local functions to resolve start‑up and ramp‑up issues and mitigate operational risks. /li liSupport generation and improvement of required GMP documentation. /li liSupport the technical implementation of New Product Introductions (NPI) in F2P2 and responsibility for successful aseptic process simulation (APS) with hand‑over to operational team. /li /ul h3Qualifications /h3 ul liCompleted vocational training in the pharmaceutical field or a BSc in Pharmaceutical, Biochemical, Chemical, or related Sciences. /li liAt least 5‑7 years of professional experience in related activities in the pharmaceutical industry. /li liExcellent technical understanding of aseptic manufacturing technologies and processes. /li liProduction experience within a GMP regulated environment is mandatory. /li liStrong knowledge of Annex 1 requirements and contamination control principles in aseptic manufacturing environments. /li liExcellent interpersonal skills. /li liChange management skills. /li liProject leadership experience. /li liExcellent analytical skills, communication strength, empathy, assertiveness and high customer and business orientation. /li liVery good level of German and English both spoken and written. /li liExperience supporting facility start‑up, operational readiness, technology transfer, and qualification activities is highly desirable. /li /ul /p #J-18808-Ljbffr