Validation Manager
4 days ago
Position OverviewThe Validation Manager will be responsible for management, scheduling and/or hands-on drafting and executing of qualification/requalification of Facilities, Utilities, System and Equipment (FUSE) for one of the 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300).
The Validation Manager will be responsible for updating the corresponding manufacturing building's Systems Master List, Requalification Schedule, and management of Validation Engineers/Specialists for day-to-day validation activities.Reports to: Associate Director, ValidationWork Location: College Station, TXCompany OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us.
We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.
Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.Job DescriptionPrimary Responsibilities:Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.Supervise the activities of the corresponding manufacturing building's internal validation staff as well as external validation contractors.
Establish validation priorities to ensure that deadlines are met.Pre-approve qualification protocols and post-approve summary reports.Perform assessments of all change controls with an accurate understanding of the implications of changes.Create, review, and update VPPs, SIAs, Risk Assessments, SOPs, forms, templates, documentation, and files.Monitor the performance of the validation activities of the corresponding manufacturing building by tracking appropriate metrics and reporting the results to Validation's Associate Director/Director.Perform other duties as needed.Qualifications:Master's Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;Bachelor's Degree and 7+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.Degree in Engineering or Science discipline is preferred.4+ years' experience in supervision of personnel.Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.Strong working knowledge of engineering principles.Solid working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.In-depth knowledge of ISPE Baseline 5, Vol.
2 – Commissioning and Qualification and FDA industry regulations.Excellent written and oral communication skills.Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint).Efficiently manage validation staff in a fast-paced, state-of-the-art, alternately research and customized manufacturing facility.Role model for company core values of trust, delighting our customers, Gemba, and Genki.Physical Requirements:Experience prolonged sitting, some bending, stooping, and stretching.Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.Operation of test equipment such as temperature logger equipment, fog machine, air sampling equipment.Working on ladders.Attendance is mandatory.Join us
FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.
We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (****** or (979) 431-3500).
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