Quality Engineer

Bachem AG•Vista, CA

18d

About The Position

The Quality Engineer (QE) / Validation 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

Requirements

Bachelor’s degree in science discipline (chemistry, biochemistry, biology or equivalent)
5+ years of Commissioning, Qualification & Validation (CQV) / cleaning validation experience in a GMP/GDP environment
Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units
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
Experience with developing coupon spike and recovery studies for cleaning validation
Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems
Understanding of cleaning validation requirements for pharmaceutical industry
Knowledge of and ability to perform MAC calculation for APIs
Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.
Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo, including use of chemicals and their interactions, danger signs, production techniques, and disposal methods.
Mid or large-size CapEx project experience
General lab instrumentation knowledge and operation experience.
Capable of working methodically and adhering to rules and regulations.

Nice To Haves

Master's degree (preferred)

Responsibilities

Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports
Perform, coordinate, execute and analyze cleaning recovery studies.
Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.
Provide qualification / validation guidance and strategy during project planning and development phases.
Train, coach and mentor team members.
Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.
Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.
Independently conduct and document investigations related to validation studies.
Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.
Accountable for the accuracy and validity of testing results
Support and assist with inspections and audits.
Plan and perform required periodic re-validation / re-qualification activities
Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.
Adherence to cGMP and safety procedures and contribute to GMP systems improvements.
Perform other related duties as assigned.