(Sr) Director, Validation Engineering

Eyepoint Pharmaceuticals-posted 6 months ago
Full-time • Senior
Hybrid • Northbridge, MA
Chemical Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

EyePoint Pharmaceuticals is seeking a motivated (Sr) Director of Validation Engineering with excellent interpersonal skills to join our team. This person will report to the Chief Manufacturing Officer and will be responsible for improving and executing a comprehensive validation program spanning two facilities. This role ensures that equipment, utilities, facilities, manufacturing processes, cleaning processes, and computer systems are validated in compliance with cGMP regulations, FDA guidelines, and international regulatory requirements. The ideal candidate possesses the ability to develop credibility and trust as a technical leader to contribute to the company's growth, productivity, and innovation. This position is located at our Northbridge, MA site with occasional travel to our Watertown, MA facility.

  • Develop, implement, and maintain the Operations validation strategy aligning with key business deliverables and compliance.
  • Collaborate closely with Quality Engineering to drive execution of Master Validation Plans for systems and processes.
  • Provide industry guidance and leadership supporting complex validation challenges.
  • Lead and manage all aspects of validation lifecycle activities, including IQ, OQ, PQ, PPQ, and requalification.
  • Author, review, and approve validation protocols, reports, and associated documentation (e.g. URS, FS, trace matrices).
  • Ensure timely completion of validation initiatives through project, budget, and resource management.
  • Serve as primary validation SME for validation topics during internal and external audits, including regulatory inspections and client visits.
  • Oversee resolution of validation-related deviations, investigations, and CAPAs.
  • Foster culture of quality, continuous improvement, and professional growth within department.
  • Collaborate effectively cross-functionally with broader organization, including Quality, Manufacturing Operations, Facilities, Engineering, R&D, Regulatory Affairs, Project Management, and Supply Chain.
  • Bachelor of Science required; Master's degree preferred.
  • A minimum of 12-15 years of experience in the pharmaceutical and/or medical device industry.
  • Extensive experience with GMP manufacturing processes, equipment, facilities, and systems.
  • Deep knowledge of GAMP5 and ISPE validation standards.
  • Strong analytical and problem-solving abilities with attention to detail.
  • Ability to influence and collaborate effectively with diverse stakeholders at all levels of the organization.
  • Strong commitment to compliance and ethical standards.
  • Ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
  • Experience with electronic Quality Management Systems (eQMS) and validation software (e.g., AssurX, Veeva).
  • Stay current with industry best practices, new technologies, and evolving regulatory landscape.
  • Robust total rewards in a science-based entrepreneurial culture.
  • Opportunities for professional growth and development.
  • A culture that empowers curiosity and innovation.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Validation Engineer Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service