Specialist, Global Analytical Instrument Validation (On-site)

About the role

The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations department is seeking a Specialist to lead validation of novel computerized analytical instruments across multiple GMP labs in the United States and Switzerland.

Key responsibilities

• Partner with scientific teams across Development Sciences & Clinical Supply to drive compliance and operational excellence.
• Validate novel, time‑sensitive instrumentation in GMP environments to meet 21 CFR Part 11 requirements.
• Support global System Development Life Cycle (SDLC) standardization and maintain inspection readiness.
• Draft and maintain Standard Operating Procedures and manage investigations and change‑management records.
• Contribute to digital‑innovation projects that improve consistency, compliance and efficiency.

Required profile

• Bachelor’s degree or higher in analytical science, information technology or related field.
• At least 3 years of relevant industry experience, preferably in a GMP laboratory.
• Strong technical problem‑solving ability and willingness to learn new concepts, including AI applications.
• Excellent verbal and written communication skills and ability to work both independently and in multidisciplinary teams.

Required skills

• Analytical Instrumentation
• Computer System Validation (CSV)
• GMP laboratory practices
• SOP writing and technical documentation
• Data analysis and equipment maintenance

What we offer

• Base salary range $96,200 – $151,400 per year, with eligibility for annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k) retirement plan, paid holidays, vacation and sick days.
• Inclusive workplace committed to diversity, equity and inclusion.