Process Engineer

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Process Engineer (m/w/d) -100%

Location: Grenchen (SO), Switzerland

Type of Contract: Permanent position

Startdate: in alignment with the candidate’s availability

Job Summary

The Process Engineer is responsible for supporting and improving manufacturing processes to ensure product quality, compliance, and operational efficiency. This role will lead non-conformance (NC), CAPA and audit observation investigations, ensure accurate documentation, and manage process validation activities (IQ/OQ/PQ). Additionally, the Process Engineer will drive process optimization initiatives, update work instructions, and collaborate cross-functionally to maintain compliance with internal procedures and regulatory requirements.

YOUR RESPONSIBILITIES

• Lead and document investigations of quality issues (non-conformances (NCs), CAPAs, Audit observations) including product bounding and disposition, root cause analysis, definition of corrective and preventive actions and compliance with quality standards.
• Lead cross-functional investigation teams for quality issues ensuring timely completion of investigation and implementation of corrections, corrective and preventive actions.
• Prepare, review, and maintain documentation related to NCs, validations, and process improvements in line with regulatory and company requirements.
• Serve as subject matter expert (SME) for deviations in internal and external audits
• Plan, execute, and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Analyze manufacturing processes and identify opportunities for optimization to improve quality, cost efficiency, and throughput.
• Revise and update work instructions, standard operating procedures (SOPs), and other process documentation to reflect changes and improvements.
• Ensure compliance with applicable industry standards, quality management systems, and regulatory requirements (e.g., ISO, FDA, GMP).
• Collaborate with cross-functional teams (Quality, R&D, Production, Supply Chain, etc.) to support product and process improvements.
• Provide technical support and training to production personnel to ensure proper execution of validated processes.
• Support continuous improvement initiatives and contribute to the development of best practices within the manufacturing environment.

YOU ARE REPORTING TO

Process Engineering Supervisor II

YOUR BACKGROUND

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
• Proven experience in manufacturing or process engineering, or quality engineering (experience in regulated industries such as medical devices, pharmaceuticals, or aerospace preferred).
• Strong knowledge of NC/CAPA processes and of validation requirements (IQ/OQ/PQ).
• Familiarity with regulatory and quality standards (e.g., ISO 13485, FDA 21 CFR Part 820, GMP).
• Excellent problem-solving, analytical, and documentation skills.
• Proficiency in process improvement tools and methodologies (Lean, Six Sigma preferred).
• Strong communication and teamwork skills with the ability to influence and drive results.
• Proven experience in project leadership
• Fluent in English. Fluency in German is preferred

Soft Skills

• Attention to detail and strong organizational skills.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Continuous improvement mindset and proactive approach to problem-solving.
• Commitment to quality and compliance

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