Validation Specialist

We are seeking a Validation Specialist for a contract opportunity supporting laboratory equipment validation within a regulated pharmaceutical manufacturing environment in Jayuya, Puerto Rico. This on-site role is ideal for a detail-oriented professional with early career validation experience who is ready to contribute to critical qualification activities in a cGMP setting.

The Validation Specialist will work closely with Quality, Laboratory, Engineering, Manufacturing, and other cross-functional teams to execute validation protocols, document results, resolve discrepancies, and support equipment readiness. This is a strong opportunity to build hands-on experience in laboratory equipment qualification while working in a structured, compliance-focused environment with collaborative teams and experienced technical leadership.

Key Responsibilities

- Execute validation and qualification activities for laboratory equipment in accordance with approved protocols, SOPs, cGMP requirements, and regulatory standards.
- Support the development, review, execution, and completion of validation protocols, including IQ, OQ, and PQ activities as applicable.
- Accurately document validation results, supporting evidence, discrepancies, deviations, and protocol execution details.
- Review equipment documentation, specifications, manuals, calibration records, and related technical information.
- Collaborate with Quality, Laboratory, Engineering, Manufacturing, and other teams to support validation execution, investigations, corrective actions, and equipment readiness.
- Maintain validation records and manage assigned deliverables to meet project timelines and quality expectations.

Compensation and Benefits

- Pay Range: $25.00 to $45.00 per hour.
- Job Type: Contract/Temporary.
- Project Duration: Approximately 1 year.
- Location: Jayuya, Puerto Rico.
- Work Arrangement: On-site.

Required Qualifications and Skills

- 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.
- 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, SOPs, and validation documentation requirements.
- Ability to accurately document protocol execution, results, discrepancies, and supporting evidence.
- Strong attention to detail and ability to work effectively in a regulated environment.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple assignments and meet established timelines.
- Ability to work independently and collaboratively with cross-functional teams.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Bilingual English and Spanish communication skills, written and verbal.
- Ability to work on-site in a pharmaceutical manufacturing and laboratory environment.
- Ability to stand for extended periods, climb ladders or steps when required, lift up to 25 lbs., and wear required gowning and PPE.
- Ability to work extended shifts as needed based on project requirements.

Preferred Qualifications

- Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Familiarity with laboratory equipment commissioning and readiness activities.
- Experience supporting validation investigations, discrepancies, deviations, and corrective actions.
- Prior exposure to GMP laboratory or manufacturing environments.

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