Sr. Quality Engineer

A brief overview

The Sr. Quality Engineer (Validation Engineer) fulfills a critical role in GMP operations. Develop strategy, plan and execute qualification of equipment, facilities, critical utilities and cleaning validation activities for API, Support CAPEX projects. Generate and execute validation/ qualification / validation protocols, reports, Validation Plans and other technical documents, as well as conduct related investigations. 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.

What you will do

• 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 Quality Engineer I and II.

• 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 l inspections and audits.

• Perform other related duties as assigned.

• 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.

Qualifications

• Bachelor’s degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent)

• Master’s degree in science related field (engineering, chemistry, biology or equivalent) (preferred)

• Minimum of 5 years of hands-on experience in cleaning validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in 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 and knowledgeable of cleaning validation requirements for pharmaceutical industry.

• Knowledge of and ability to perform MAC calculation for APIs.

• Understanding of Good Manufacturer Practice for Active Pharmaceutical Ingredients per ICH Q7.

• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.

• General lab instrumentation knowledge and operation experience.

• Capable of working methodically and accordingly adhering to rules and regulations.

• Entering or recording information in written or electronic form.

• Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innov