What are the responsibilities and job description for the Validation Engineer position at United Consulting Hub?
Job Title: Validation Engineer
Location : New Jersey
Position Overview:
We are seeking a skilled and experienced Validation Engineer with a strong background in Utilities Validation (e.g., compressed air, chillers, WFI, etc.). The successful candidate will be responsible for executing and managing IQ/OQ/PQ protocols. Additionally, proficiency in CAD is essential as the role requires updating P&ID (Piping and Instrumentation Diagrams).
The role will also involve using pre-existing water system protocols from another site and adjusting them to suit the New Jersey location. The focus will be on validating critical systems, including cleaning and sanitization processes, water systems, utilities, and computer control systems.
Key Responsibilities:
- Develop, execute, and maintain validation protocols for critical utility systems, including compressed air, water, and other key plant utilities.
- Manage validation efforts for Cleaning & Sanitization (C&S) processes, water systems, and computer control systems.
- Update and modify P&ID (Piping and Instrumentation Diagrams) using CAD tools.
- Ensure the site’s Validation Program integrates seamlessly with other quality systems, such as Management of Change (MoC), Technology Transfer, Calibration, Facilities & Equipment, and Preventive Maintenance.
- Review and adjust water system protocols from another site to fit the NJ location’s needs.
- Collaborate with cross-functional teams to support validation efforts and ensure compliance with regulatory requirements.
- Provide expertise in the validation of utilities and critical systems, ensuring they meet quality and safety standards.
Qualifications:
- Experience in utilities validation, including systems such as compressed air, chillers, WFI, and others.
- Proven ability to develop and execute IQ/OQ/PQ protocols.
- Strong knowledge of P&ID diagrams and proficiency in CAD software to update and revise diagrams.
- Familiarity with cleaning & sanitization (C&S) processes and water system validation.
- Must have experience with OTC drug products; pharma experience is a preferred trade-off.
- In-depth understanding of validation processes and integrating these with plant quality systems.
- Strong communication skills and the ability to collaborate effectively with cross-functional teams.
