Sr Engineer

Validation &

• Engineering Group Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position Sr Engineer Description Independently provides andor directs the characterization of process optimization strategies andor troubleshooting of operational issues in the operations manufacturing pilot plant or capital projects environment Applies advanced and diverse engineering principles to the design and implementation of major system modifications experiments process andor capital projects Develops organizes analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity Qualifications Engineer with years of experience preferably in aseptic processing environments including FillFinish operations such as vial and syringe filling linesExperience in characterization activities and performance qualification PQ for New Product Introductions NPIMinimum of 4 years of experience in direct pharmaceutical medical device or biotechnology industriesExperience in direct process manufacturing areasMust be fully bilingual English Spanish with excellent oral skillsMust be proficient using MS Windows and Microsoft Office applicationsStrong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory complianceExperience in Design Documentation URS DS IQ OQ PQ protocols development and execution deviations and reports generationSDLC Risk Assessment Data Integrity Factory Acceptance Test FAT &
• Site Acceptance Test SATAvailable to work extended hours possibility of weekends and holidays Education Masters 2 years of Engineering experience OR Bachelors in Engineering 4 years of Engineering experience Preferred Mechanical or Chemical Engineering CompetenciesSkills Working knowledge of pharmaceuticalbiotech processesFamiliarity with validation processesFamiliarity with documentation in a highly regulated environmentAbility to operate specialized laboratory equipment and computers as appropriateAbility to interpret and apply GLPs and GMPsAbility to apply engineering science to productionAble to develop solutions to routine technical problems of limited scopeComprehensive understanding of validation protocol execution requirementsAt Validation &
• Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you Validation &
• Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status