- Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies.
- Ensure compliance and the validated state of all GXP systems.
- Partners with cross-functional groups for GXP system implementation projects and ongoing validation needs including revalidation, periodic review of system controls, security, and segregation of duties.
- May be responsible to manage external CSV consultants in CSV projects.
- Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles and GAMP5 practices.
- Serve as the subject matter expert (SME) regarding Data Integrity and CSV lifecycle.
- Develops and prepares all validation deliverables for approval.
- Support computer systems Risk Based Assessment and gap assessment remediation activities.
- Creates and/or revises CSV procedures, forms, and templates for continuous improvement.
- Owns CSV-related Deviations and CAPAs. Manages remediation efforts related to CSV and Data Integrity.
- Partners with IT to establish back-up/restore, disaster recovery, adherence to retention schedules, and establish requirements for infrastructure qualification.
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
- Manages the authoring and dry running of IQ, OQ and PQ test scripts.
This role would be Hybrid at our Redmond, WA office.
Requirements:
- GMP computer systems experience required.
- Working knowledge of GxP regulations and CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
- Knowledge of Quality Risk Management per ICH Q9 and its application to CSV.
- 5+ years of GxP CSV experience.
- Thorough understanding of validation/qualification concepts as it applies to pharmaceuticals quality systems.
- Possess strong technical writing skills.
- Must have excellent communication skills (both oral and written), including the ability to effectively communicate across organizational levels and functions.
The base pay range for this position at commencement of employment is expected to be $130,000 to $150,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
About Us
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to and follow us on X/Twitter @Evotec and LinkedIn.
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