GxP Validation Manager

Location{{:}} Bloomington, IN**This role will require full-time presence (5 days / week) at the client site in Bloomington, IN**** This role is not eligible for relocation assistance**Zifo is looking for a GxP Validation -Manager to join our team in Bloomington, Indiana. Responsible for leading the GxP Validation, Data Integrity and Remediation efforts for Analytical Instruments and Computerized Systems in accordance with applicable policies procedures and regulatory requirements.Job ResponsibilitiesDefine validation Strategy for computerized systems and analytical instruments utilized in GxP QC and Manufacturing labsUnderstand SDLC process and SDLC methodology such as agile etcCreate and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systemsParticipate/conduct Risk AssessmentsDevelop and maintain policies and proceduresExperience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)Perform Data Integrity Assessments for analytical instruments and Computerized systems and conduct meetings with stakeholders to discuss on the remediations of observations from review. Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systemsParticipate in user review meetings, discussions with Quality Assurance and Compliance groupsMust have experience working with global team (offshore) in delivering validation project deliverables and collaborate with global team towards project successEffectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within ZifoAct as a liaison between Zifo remote teams and customersResponsible for Project Risk Management, escalation management, stakeholder communication, status reporting etcAuthor/Review validation life cycle documents for client's review and approvalAct as a business consultant to support end users of the systemRoute drafted documents for reviewRoute reviewed documents for workflow approvalRequest approval workflows for documentsExecute approved qualification protocols in GxP facility along with SMEs. Must be aware of using electronic document management systems to create and execute qualification protocolsUnderstand and manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control areaParticipate in internal initiatives around Compliance and ValidationRequirementsQualificationsBachelor or Master's degree in Lifesciences or Computer Sciences7+ years' experience with Computer Systems Validation is required for this roleStrong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirementsExperience with laboratory or GxP systems validation like ELN, LIMS, QMS and Instrumentation Systems etcExperience with working on long term multiple site engagements and remediation programsBenefitsCURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals.  While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.  If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.