About this opportunity
Bachem Holding AG lists this Sr / Principal Validation Engineer opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
A brief overview
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see .
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)
5+ years of Commissioning, Qualification and Validation (CQV) 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 (preferred)
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.
General lab instrumentation knowledge and operation experience.
Capable of working methodically and adhering to rules and regulations.
Base salary range:
Principal Engineer: $120,875 - $166,204
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards
competitive pay
annual performance bonus
a generous benefit package with comprehensive Medical/Dental/Vision coverage
401(k) plan with employer contribution
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 Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
At Bachem , you’ll find a diverse, multicultural team. The (a) in the job title stands for all . We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.