Process & Validation Engineer — CQV Expert (Hybrid)

SHL Medical AG; Zug; Hybrid; CHF 110,000 - 170,000; Full time

Benefits offered by this job

Challenging projects in fast-growing/ā

Multicultural team

State-of-the-art facilities

Hybrid working policy

Global development opportunities

Job summary

SHL Medical AG in Zug is seeking a Process/Validation Engineer to join the Operations Engineering Team at our state-of-the-art facility. You will act as a process SME, drive CQV activities, and support validation plans and protocols for production equipment and processes.

The role requires 3+ years in medical device process/validation, experience with DOE/RCA, and fluency in English and German. Hybrid work and global collaboration are offered along with development opportunities.

Qualifications

• Must-have: extensive experience as Process Engineer and/or Validation Engineer in medical device manufacturing.
• Strong knowledge of CQV (commissioning, qualification, validation) and validation lifecycle.
• Proficient in DOE, RCA methodologies; Six Sigma is a plus.
• Fluent written and spoken English and German.

Responsibilities

• Act as a process SME, leading and supporting process introduction, development, troubleshooting, and improvement initiatives at the site.
• Lead and support acceptance and CQV activities for production equipment and processes, including developing compliant validation plans and protocols; support change control.
• Collaborate across departments to drive improvements to SHL’s production equipment and processes; drive efficiency and robustness in validation updates.
• Provide input to validation SOPs and work instructions; update documentation.
• Support internal and external audits with validation documentation ownership and SME input.
• Stay up-to-date with industry trends and quality systems (ISO13485, cGMP, CFR 820).
• May perform other related duties as assigned.
• Minimum of 3 years of relevant experience; high-volume production experience (injection molding, packaging/printing, metal forming) preferred.

Skills

Process Engineering

Validation Engineering

DOE (Design of Experiments)

Root Cause Analysis

English & German fluency

Job description

SHL Medical AG in Zug is seeking a Process/Validation Engineer to join the Operations Engineering Team at our state-of-the-art facility. You will act as a process SME, drive CQV activities, and support validation plans and protocols for production equipment and processes.

The role requires 3+ years in medical device process/validation, experience with DOE/RCA, and fluency in English and German. Hybrid work and global collaboration are offered along with development opportunities.