Operations Engineer

Due to investing in a state-of-the-art production unit for the aseptic filling and lyophilization of highly potent, biotechnologically produced active ingredients on a commercial scale, my client are looking for a future Operations Engineer with several years of experience in the field of Fill & Finish and ideally lyophilization. They should enjoy working in a team on the planning, organizational development and commissioning of the area. After completion of the project, you will take on responsibility as an operations engineer for the newly established area. This gives you the opportunity to play a significant role in shaping your future work area.

Responsibilities during the design phase:

• Close cooperation with the Fill & Finish project manager, the project team, external service providers and, in particular, the overall project manager
• Collaboration in the planning / design of cleanrooms and production facilities, taking into account the requirements regarding GMP, reliability, capacity and EHS
• Participation in the implementation of FATs and SATs
• Support of qualifications (e.g. PQ) and validations (e.g. cleaning, sterilization) for systems and devices as well as preparation of SOPs and risk analyses together with the team and external service providers
• Implementation of training courses

Responsibilities after commissioning:

• Technical support of the process plants as well as project planning of upgrades / optimization measures
• Ensuring GMP and EHS compliance of the technical equipment and its operational readiness
• Trouble-shooting, root cause analyses and support of the operations department in the GMP-compliant processing of deviations and implementation of CAPA measures and change control procedures
• Preparation of SOPs, risk assessments and risk analyses as well as implementation of employee training courses
• Evaluation of production and plant-relevant data
• Participation in FATs, SATs together with engineering
• Close cooperation with the engineering, EHS, IT and supplier departments
• Collaboration in the preparation and implementation of audits and inspections

Requirements:

• Degree in pharmaceutical technology or engineering, preferably in the field of biotechnology / process engineering / mechanical engineering or comparable qualification
• Several years of experience in the operation of pharmaceutical plants or their project planning in the field of fill and finish, ideally also with freeze-drying
• Good knowledge of pharmaceutical manufacturing processes, equipment qualification and EHS requirements
• Sound knowledge of legal regulations (national and international)
• Affinity for digital and innovative technologies
• Good MS Office and Sharepoint skills
• Good teamwork and communication skills (also on an international level) as well as precise working methods and flexibility
• Assertiveness, independent way of working, commitment and resilience, hands-on mentality
• Very good knowledge of German and English, both written and spoken

Apply below!