Validation Expert

Automation Validation Engineer

About the Role:

The Automation Validation Engineer is responsible for providing validation and compliance project support to different business divisions and technology verticals. This includes developing and managing GxP system lifecycle documentation, writing and executing IQ and OQ protocols, communicating with vendors, managing and coordinating all aspects of the validation activities, maintaining SOPs, and identifying risks.

Key Responsibilities:

• • Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Requirements Traceability Matrix, Validation Summary Reports, Standard Operating Procedures, Change Control Documentation, and Risk Assessment reports.
  • Writing and executing IQ and OQ protocols.
  • Communicating with vendors to ensure project requirements are being met.
  • Managing and coordinating all aspects of the validation activities, including project planning, developing validation strategies, document development and document reviews, overseeing system change requests and associated documentation.
  • Maintaining SOPs pertaining to the Quality Management System utilizing a risk-based approach (GAMP5) to determine the validation requirements.
  • Configuration specifications generation detailing the specific configuration of the systems/interfaces.
  • Project change control implementation in accordance with requirements, design, and system changes.
  • Identification of risks and clear communication to project stakeholders.

Requirements:

To be successful in this role, you will need:
• A minimum of Bachelor's degree preferably in Chemical Engineering but Mechanical Engineering, Electrical Engineering, Computer Engineering, Industrial Engineering, or related also considered.
• Excellent technical writing and communication skills.
• Experience in the Life Sciences, Pharmaceutical, Medical Devices industries preferred.
• Experience in systems validation/QA within FDA (GxP) regulated environments preferred.
• Experience with industrial process validation essential.
• Ideally, experience with equipment validation, instrument validation, and packaging validation is preferred.
• Experience with validating and qualifying various software and IT systems utilized in the industrial automation environment.
• Experience in developing full validation lifecycle documentation and testing protocols (IQ/OQ/PQ) with thorough knowledge of GAMP5 concepts.
• Experience of validating a serialization or track & trace systems preferred.

What We Offer:

We offer a competitive compensation package, annual performance-based raises and bonuses, 401(k) savings plan(s) with company matching, paid Time Off Packages Medical, Dental, Life, Short & Long-Term Disability benefits, a structured approach to career and professional development opportunities, sponsored professional events & training programs, and more.

An Equal Opportunity Employer:

Catalyx is an equal opportunity employer with a strong commitment to supporting and retaining a diverse and talented workforce.