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Validation Specialist II, Associate
2 months ago
Job Summary
This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities, and computer systems utilized in the manufacture of product are validated for intended use.
The Associate Specialist II, Validation executes qualification and validation documents, including process equipment, controlled environments, critical utilities, critical facilities, and decontamination/sterilization of equipment.
Key Responsibilities
- Develop and execute validation strategies, timelines, and resource requirements for new and existing facilities, utilities, and equipment.
- Coordinate, communicate, and complete assigned validation tasks.
- Operate instrumentation to perform environmental monitoring studies.
- Review User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests for facilities, equipment, and utilities.
- Author documents, such as procedures, summary reports, and status reports, related to data integrity.
- Function as system administrator for defined computerized systems.
- Work with cross-functional teams to develop and execute validation activities associated with new equipment, system, and facility upgrades.
- Review and approve documents prepared by the validation team, other departments, and contractor organizations.
- Resolve and assist in the closure of deficiencies/deviations initiated during validation activities or related to critical process parameters.
- Assist in the implementation of the validation program to ensure continued compliance to necessary regulations.
- Participate in audit interviews and support audits performed by regulatory agencies.
Requirements
- Bachelor's degree in Engineering, Chemistry, Microbiology, or related field.
- Desirable cGxP validation experience in data integrity, installation qualification, operational qualification, and performance qualification.
- Experience with investigations and root cause analysis principles.
- Excellent technical writing and verbal communication skills.
- Demonstrated ability to manage complex validation projects in a fast-paced environment.
Skills
- Strong knowledge of engineering and related practices, including governmental regulations.
- Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, and equipment, preferably used in a GMP environment.
- Success in technical proficiency, creativity, and collaboration with others and independent thought.
- Excellent attention to detail, with an ability to work to very tight schedules.
- Ability to adapt to a dynamic project schedule with varying levels of complexity.
- Advanced skills and fluency in Microsoft Word, Outlook, and Excel.
- Experience with laboratory instrumentation/equipment and control systems used in GMP and/or GLP environment.
- Strong communication and project management skills.
- Adaptable and flexible.
