Validation Specialist I
About The Position
The Validation Specialist I is responsible for supporting the execution of validation activities for laboratory equipment within a regulated pharmaceutical manufacturing environment. This position will support the qualification and validation of various laboratory instruments and equipment, ensuring compliance with applicable cGMP requirements, company procedures, validation protocols, and regulatory standards. The role requires hands-on participation in validation execution, documentation, discrepancy resolution, and collaboration with Quality, Laboratory, Engineering, and other cross-functional teams.
Requirements
- Bachelor’s degree in Chemistry, Chemical Engineering, or a closely related scientific or engineering discipline.
- Minimum of 1 year of hands-on experience in validation or qualification of laboratory equipment, preferably within the pharmaceutical, biotechnology, medical device, or other regulated industry.
- Experience executing validation protocols for laboratory instruments and equipment.
- Basic knowledge of equipment qualification concepts, including IQ, OQ, and PQ.
- Knowledge of cGMP, Good Documentation Practices (GDP), SOPs, and validation documentation requirements.
- Ability to accurately document protocol execution, results, discrepancies, and supporting evidence.
- Strong attention to detail and ability to work in a regulated environment.
- Ability to manage multiple assignments and meet established timelines.
- Ability to work independently as well as collaboratively with cross-functional teams.
- Strong organizational, analytical, and problem-solving skills.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Bilingual in English and Spanish, written and verbal.
Responsibilities
- Execute validation and qualification activities for laboratory equipment in accordance with approved protocols, SOPs, and applicable regulatory requirements.
- Support the development, review, execution, and completion of validation protocols and related documentation.
- Perform equipment qualification activities, including applicable IQ, OQ, and/or PQ activities.
- Document validation results accurately and ensure appropriate traceability of executed activities.
- Identify, document, and support the resolution of discrepancies or deviations encountered during protocol execution.
- Support investigations and corrective actions associated with validation activities when required.
- Review equipment documentation, specifications, manuals, calibration records, and other supporting technical information.
- Ensure validation documentation complies with cGMP, Good Documentation Practices (GDP), company procedures, and regulatory expectations.
- Collaborate with Laboratory, Quality, Engineering, Manufacturing, and other cross-functional teams during validation activities.
- Support equipment commissioning and readiness activities as required.
- Maintain validation documentation and records in accordance with established procedures.
- Manage assigned activities and deliverables to meet project timelines and quality expectations.
- Participate in project meetings and provide status updates regarding validation activities.
- Perform additional validation-related responsibilities as assigned based on project and client needs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
