Validation Supervisor
Sterling Life Sciences - Detroit, MI

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1) Lead a group of 3 - 5 employees and support equipment and cleaning validation activities
2) Prepare qualification protocols for facility, utility and equipment systems, cleaning and shipping
3) Execute the qualification protocols after protocol approval and prepare validation summary reports
4) Provide validation advice and guidance to project teams and other functional groups
5) Ensure required supplies are present and that the equipment used for validations is calibrated and documented
6) Accumulate, document and communicate validation data and activities
7) Mentor and supervise other validation professionals
8) Manage multiple projects and provide effective communication to colleagues, customers and management
9) Provide validation advice and guidance to project teams and other functional groups
10) Prepare validation documentation, including qualification protocols for facility, utility and equipment systems, validation protocols for cleaning and shipping validation, protocol deviations, risk assessments and reports
11) Approve validation documentation, including protocols, protocol deviations, reports, work orders, validation assessments to support change controls and deviations
12) Prepare CTDs for submissions to FDA
13) Represent validation during FDA and other regulatory agency inspections and customer audits
14) Support validation training, including developing and implementing validation training to department and customers
TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceuticals industry is strongly preferred
4) Preference will be given to people who have recent experience in validation supervision

CareerBuilder - 17 months ago - save job - block
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