Quality Engineer - Pharmaceuticals - 1859 - CA

Relocation is available

5% performance bonus, 3% safe harbor company contribution and stellar benefits

The Quality Engineering / Senior Quality Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations.

REQUIRED EXPERIENCE & SKILLS:
3+ years of hands-on experience in cleaning validation in a quality control analytical laboratory in a GMP/GDP environment
3+ years of hands-on experience planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
Understanding of cleaning validation requirements for pharmaceutical industry
BS in chemistry or related

DESIRED EXPERIENCE & SKILLS:
Experience with peptide or amino acid pharmaceutical manufacturing
Experience with developing coupon spike and recovery studies for cleaning validation
Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations
Six Sigma certification
MS in chemistry or related

Education:
University - Bachelor`s Degree/3-4 Year Degree