Senior Validation Engineer

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Independence, Missouri

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Tue, 15 Dec 2020 23:59:59 GMT

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Job Title: Senior Validation Engineer Job Description: Contribute to outstanding innovation + Make braver choices Senior Validation Engineer Location: Parsippany As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our people first philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the worlds oldest enemy: disease. Responsibilities: – Supervise / review commissioning, qualification, work performed by Validation Specialists and / or Validation contractors. – Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects. – Monitor and track protocol and report status. – Assist / mentor Validation Specialists on GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists that they are working on. – Will also monitor and track these documents to ensure that they are completed on time. – Mentor / train / assist Validation Specialists with Cleaning Validation, Equipment / Utilities Qualification, Process Validation, Computer Validation principles. – Review, supervise, and track commissioning, qualification, validation projects from other Validation Specialists and / or Validation contractors through Microsoft Project or tracking spreadsheets to ensure work is completed on time. – Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning and process non-conformances. Also lead Trackwise deviations, CAPAs and change controls issued to the department. Ensure that they are properly tracked, closed on time or extended if necessary. – Be able to answer questions during internal and external audits. – Take the lead in ensuring that deviations, CAPAs, and change controls issued to the department are properly tracked, closed on time, or extended if necessary. – Update yearly Validation Master Plan. SME on at least two (2) of the Qualification / Validation subjects specified below and thorough hands on experience on at least seven (7) of the ten (10) subjects: – Sterile Process Equipment Qualification – Packaging Equipment Qualification – Media Fills – Utilities Commissioning / Qualification – Cleaning Verification / Validation – Process Validation – QC Equipment Qualification – QC Test Method Validation – Computer Validation – Environmental Monitoring Qualification of Classified Areas Requirements: – Bachelors degree in Engineering or related field, or equivalent combination of education and work-related experience, required. – Minimum 5+ years Qualification (IQ, OQ, PQ) / Validation (PV, CV) experience. Join our team and youll become part of a close-knit family one in which youll be listened to and your contributions valued. Surrounded by like-minded people, youll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Parsippany