Job Summary:
The Validation Specialist – Utilities is responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards. This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air, HVAC, and clean steam. The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations.
Responsibilities:
- Develop, execute, and maintain validation protocols and reports for utility systems, including water systems, compressed air, HVAC, and clean steam.
- Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform risk assessments to identify critical control points and ensure compliance with GMP and regulatory standards.
- Monitor and evaluate the performance of utility systems to ensure consistent operation within validated parameters.
- Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to define validation requirements and strategies.
- Develop and implement protocols for periodic review and requalification of utilities systems.
- Analyze validation data to identify trends and recommend improvements to utility system performance and compliance.
- Manage deviations and non-conformances related to utility system validation, ensuring timely investigation and resolution.
- Provide support during regulatory audits and inspections, offering expertise in utilities validation and compliance.
- Maintain detailed and accurate documentation of all validation activities and changes to utility systems.
- Stay current with industry trends and regulatory updates, ensuring compliance and best practices in utilities validation.
Qualifications:
- Bachelor’s Degree in Engineering, Life Sciences, or a related field.
- 2+ years of experience in utilities validation within a regulated manufacturing environment.
- Strong knowledge of GMP, FDA, and ICH guidelines.
- Demonstrated expertise in validating utility systems such as water systems, compressed air, HVAC, and clean steam.
- Experience in risk assessments, validation protocols, and data analysis.
- Proficiency in developing and executing IQ, OQ, and PQ protocols.
- Strong problem-solving and analytical skills.
- Excellent communication and interpersonal skills for cross-functional collaboration.
- Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management software.
Physical/Mental Requirements:
- Ability to work in manufacturing environments, including cleanrooms and utility areas.
- Able to stand for extended periods and climb ladders/steps as required.
- Ability to lift and move items up to 25 lbs.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.