Shawn Inks

About Shawn Inks

25 years of experience in the Pharmaceutical and Diagnostics industry, with a diverse background in Quality, Manufacturing (U.S. and Europe), Validation and Engineering. Efficient and organized team player; highly dependable and flexible. Extensive cGMP knowledge and a strong aptitude for mechanical and technically oriented tasks. Excellent written, oral and interpersonal skills. PROFESSIONAL SKILLS• Experienced in managing audits, including FDA, EMEA, HSE, internal, and external clients.• Writing, executing, preparing summary reports and reviewing data for the qualification of utilities, equipment, cleaning and processes.• Creating all levels of documentation in the Validation lifecycle approach.• Demonstrated ability to communicate clearly and effectively will all levels of staff, and present training materials to groups of all sizes.• Knowledgeable in a wide spectrum of engineering concepts, drawings and documentation. • Customer-focused, with a strong aptitude to complete time-critical tasks and stay focused in high stress situations.

Experience

1. Manufacturing Engineer Iv

   Benchmark

   Mar 2025 — Present · Concord, CA, US

Education

• UC Santa Barbara

  BA, Biology & Physical Anthropology

  1988 — 1994

Skills

• Quality System
• Quality Systems
• V&V
• Vaccines
• Gmp
• Quality Assurance
• Process Validation
• Diagnostics
• Pharmaceuticals
• Quality Auditing
• Validation
• Change Control
• Biotechnology
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• 21 Cfr Part 11
• Technology Transfer