Process and Validation Engineer

About the role

SHL Medical designs, develops and manufactures self-injection devices such as autoinjectors and pen injectors. This Process and Validation Engineer role sits in the Operations Engineering Team within the Global Operations Engineering Department at the company's new device manufacturing facility and headquarters in Zug, Switzerland. It bridges process engineering and validation, supporting onsite validation activities and acting as a process subject matter expert who drives improvements and supports investigations and troubleshooting.

Key responsibilities

• Act as a process SME, leading and supporting process introduction, development, troubleshooting and improvement at the site
• Lead and support acceptance and CQV (commissioning, qualification and validation) of production equipment and processes, including writing validation plans and protocols and supporting change control
• Drive improvements to production equipment and processes with internal and cross-departmental colleagues
• Work with the validation team, including global colleagues, to make validation updates more efficient, simple and robust
• Update validation-related SOPs, work instructions and guidelines
• Support root cause analysis, NCMR investigations and CAPA planning
• Support internal and external audits and investigations through validation documentation and technical input
• Stay compliant with Quality Systems, ISO 13485, cGMP and other regulatory protocols

Required profile

• At least 3 years of experience as a Process Engineer and/or Validation Engineer, preferably in the medical device industry
• Experience as a process SME in high-volume production (e.g. injection molding, packaging/printing, metal forming)
• Knowledge of medical device regulations and standards (cGMP, ISO 13485, CFR 820) and of quality systems in the industry
• Fluency in English and German, written and spoken
• Preferred: ability to handle multiple tasks, analytical and problem-solving skills, intercultural communication, independence and attention to detail; Mandarin fluency preferred

Required skills

• Statistical analysis, including Design of Experiments (DOE)
• Root cause analysis (RCA) methodologies
• Six Sigma certification is a plus

What we offer

• Challenging assignments in a fast-growing, innovative industry
• Multicultural team and modern facilities
• Personal and professional development opportunities
• Flexible hours and a hybrid working policy