Responsibilities:
- 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, form, 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 and 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.