Senior Compliance Engineer, Process Engineering

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Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

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:

Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection