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Senior Validation Specialist

2 months ago

Boulder, Colorado, United States AGC Biologics Full time
Company Overview

At AGC Biologics, we are dedicated to transforming lives through innovative biopharmaceutical solutions. Our commitment to enhancing patient care drives us to collaborate closely with our clients, ensuring the successful introduction of groundbreaking therapies into the market.

Position Summary

The Senior Validation Specialist plays a crucial role in ensuring the integrity of our facilities, utilities, and equipment. This position is responsible for developing and maintaining validation master plans, overseeing junior validation engineers, and managing validation projects. The ideal candidate will possess a strong background in validation processes and will be adept at training and mentoring others.

Key Responsibilities
  • Lead the development and execution of area-specific validation master plans.
  • Oversee junior validation engineers and contract personnel, ensuring effective project management and progress tracking.
  • Engage with clients during technical transfer meetings, representing equipment validation.
  • Author and review validation protocols in collaboration with engineering, manufacturing, and quality control teams.
  • Conduct qualifications of manufacturing and analytical equipment to confirm suitability for intended use.
  • Participate in the validation of clean utilities, facilities, and analytical instruments, ensuring compliance with industry standards.
  • Utilize User Requirement Specifications (URS) to create test scripts and acceptance criteria for validation protocols.
  • Investigate and resolve validation deviations, implementing corrective actions as necessary.
  • Provide technical oversight of validation deliverables and compile comprehensive summary reports.
  • Assess the impact of changes to qualified systems as part of the change control process.
Qualifications
  • Bachelor's degree or equivalent experience in biotech or pharmaceutical validation.
  • Minimum of 3 years of experience in validation within the life sciences sector, with a total of 10+ years in related fields.
  • Proficient in generating qualification protocols (IQ, OQ, PQ) and technical documentation.
  • Strong knowledge of validation life-cycle and risk-based validation approaches.
  • Excellent organizational skills with the ability to manage multiple projects simultaneously.
  • Exceptional written and verbal communication skills, capable of effectively conveying information to diverse audiences.
Compensation

AGC Biologics offers a competitive compensation package, reflecting our commitment to attracting and retaining top talent. Our culture is built on core values of Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork, fostering an environment where innovation thrives.