Sr / Principal Validation Engineer

ph3A brief overview /h3pBachem 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 . /ph3What you will do /h3ulliDevelop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports /liliPerform, coordinate, execute and analyze cleaning recovery studies. /liliLead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables. /liliProvide qualification / validation guidance and strategy during project planning and development phases. Train, coach and mentor Quality Engineer I and II. /liliWrite validation protocols and final reports, test methods, standard operating procedures, and technical reports. /liliPlanning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports. /liliIndependently conduct and document investigations related to validation studies. /liliBased on validation studies, evaluate and make recommendations for improvements to operations, processes and methods. /liliAccountable for the accuracy and validity of testing results /liliSupport and assist with l inspections and audits. /liliPerform other related duties as assigned. /liliPlan and perform required periodic re-validation / re-qualification activities /liliWork and communicate with different associates within the company to ensure timely completion of assigned tasks and projects. /liliAdherence to cGMP and safety procedures and contribute to GMP systems improvements. /li /ulh3Qualifications /h3ulliBachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent) /liliMaster’s degree in science related field (engineering, chemistry, biology or equivalent). (preferred) /lili5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment /liliExperience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports /liliExperience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units /liliExperience 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) /liliExperience with developing coupon spike and recovery studies for cleaning validation /liliExperience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems /liliUnderstanding of cleaning validation requirements for pharmaceutical industry /liliKnowledge of and ability to perform MAC calculation for APIs /liliUnderstanding of GMP for Active Pharmaceutical Ingredients per ICH Q7. /liliKnowledge 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. /liliGeneral lab instrumentation knowledge and operation experience. /liliCapable of working methodically and adhering to rules and regulations. /li /ulh3Base salary range: /h3pPrincipal Engineer: $120,875
- $166,204 /ppPlacement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. /ph3Total Rewards /h3ullicompetitive pay /liliannual performance bonus /lilia generous benefit package with comprehensive Medical/Dental/Vision coverage /lili401(k) plan with employer contribution /lilipaid vacation, personal and sick days /li /ulh3Corporate Social Responsibility /h3pBachem 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. /ph3Bachem Americas is an Equal Opportunity Employer /h3pAs 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 o