Senior Compliance Engineer, Process Engineering (m/f)

Main Tasks

The Senior Compliance Engineer, Process Engineering, is responsible for Engineering and Qualification; support Validation on process equipment, utilities & facilities and computerized systems in CM&T F2P2.

• Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
• Lead troubleshooting, corrective action and documentation efforts for technical issues and non-conformances, collaborating with production teams, equipment suppliers and Quality Assurance.
• Manage technical changes and optimization initiatives through the change control process.
• Oversee the technical work order system in cooperation with mechanics and Technical Services.
• Deliver training and instructions to operators and staff at system and process level.
• Support evaluation, qualification and implementation of new technology platforms/processes in an aseptic environment.
• Collaborate across engineering functions locally and within the global engineering organization on cross-functional projects.

Your profile

• Proven experience specifying and designing process equipment and systems for aseptic environments.
• Strong troubleshooting skills: perform root cause analysis, define corrective actions and ensure implementation and follow-up.
• Experience in process and facility engineering with hands-on support for GMP compliance of facilities, utilities and process equipment (e.g., change controls, deviations, NCs, qualifications, support for validation).
• Experience writing procedures and protocols, analysing process data and producing clear technical reports with conclusions and recommendations.
• Knowledge of HVAC systems, certification and monitoring; previous aseptic-fill/sterile manufacturing experience is an advantage.
• Ability to identify improvement projects, create project plans and participate in delivery to drive efficiency and business outcomes.
• General understanding of project budgeting and basic financial processes.
• Awareness of the department’s role within the broader organization (CSC/DPDS/IMSC) and readiness to lead project teams.
• Experience planning and coordinating validation and scale-up activities, equipment assembly, in-process sampling, reactor use and preparation of compliance documentation.
• Ability to evaluate analytical results to maintain and improve batch quality.
• Propose and implement new or improved technologies to enhance product quality, manufacturing cost-efficiency, personnel safety and regulatory compliance.
• Solid knowledge of aseptic fill-finish operations and regulatory requirements (Annex 1 / FDA guidance) and the ability to translate these into technical solutions.
• 4–6 years’ experience in the pharmaceutical, food or chemical industry.
• Fluent in German and English (written and spoken).

Required Skills:

Preferred Skills: