Purpose
To execute validation activities in compliance with regulatory requirements and company standards. The Validation Engineer supports the Validation Team Lead in implementing the Validation Master Plan, maintaining validation-related SOPs, and performing validation for processes, cleaning, equipment, analytical instruments, and utilitie
Responsibilities
* Develop, execute, and document validation protocols and reports for process, cleaning, equipment, analytical instruments, and utilities.
* Ensure validation activities comply with GMP, regulatory guidelines, and internal procedures.
* Support technology transfers and new product introductions through validation activities.
* Maintain accurate and complete validation documentation in accordance with SOPs and regulatory requirements.
* Assist in updating and implementing validation-related SOPs under the guidance of the Validation Team Lead.
* Ensure validation records are audit-ready and support internal and external inspections.
* Identify opportunities to improve validation processes and enhance efficiency.
* Contribute to initiatives that align validation practices with evolving regulatory expectations.
* Work closely with manufacturing, quality, engineering, and analytical teams to coordinate validation activities.
* Provide technical support during troubleshooting and investigations related to validation.
Requirements
* Degree in Engineering, Pharmaceutical Science, or related discipline.
* 2-4 years in validation within a GMP-regulated environment.
* Experience in process, cleaning, and equipment validation preferred.
* Strong understanding of GMP and validation principles.
* Excellent documentation and organizational skills.
* Ability to work collaboratively across functions.
* Solid knowledge of validation methodologies and regulatory requirements.
* Ensures accuracy and completeness in validation documentation.
* Ability to troubleshoot and resolve validation-related issues.
* Works effectively with cross-functional teams.
* Commitment to maintaining high standards of quality and regulatory compliance.