Summary
We seek a Validation Engineer to support the Validation Team Lead in executing validation activities across processes, cleaning, equipment, analytical instruments, and utilities, ensuring compliance with GMP, regulatory guidelines, and internal procedures.
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.
Qualifications and Experience
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.
Skills and Competencies
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.
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