Senior Quality Engineer

A brief overview

The Senior/Principal Engineer in Quality Engineering (QE) fulfills a critical role in GMP operations. This person will develop strategies, plan and execute qualification of equipment, facilities, critical utilities and cleaning validation activities for API and support Capex projects. This person will also generate and execute validation/qualification/validation protocals, reports. Complete validation plans and other technical documents, as well as conduct related investigation. 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 for 5 years of hands-on experience in cleaning validation and equipment, facility, utility qualification in a cGMP/GDP environment required, and in planning, writing and executing qualification protocols (DQ, 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, developing acceptance criteria and establishing limits. 
• Experience with addressing exceptions, deviations and CAPAs in a timely manner. 
• Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems (preferred).
• Understanding and knowledgeable of cleaning validation requirements for pharmaceutical industry.
• Knowledge of and ability to perform MAC calculation for APIs.
• Understanding of FDA and EU Equipment, Facility/ Utility and Cleaning Validation requirements, as well as Good Manufacturer Practice for Active Pharmaceutical Ingredients per ICH Q7.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.
• Coach and mentor QE personnel on qualification / validation and compliance requirements.
• Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
• Oversee the activities of contractors / vendors (as necessary) to deliver complete, accurate and on-time validation documents and packages.

Base Annual Salary Range: 

• Senior Quality Engineer: $103,939 to $142,916
• Principal Quality Engineer: $125,539 - $172,616

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards 

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. 

Corporate Social Responsibility 

 Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem. 

Bachem Americas is an Equal Opportunity Employer 

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status