Validation Specialist

Job Summary

We are seeking a Validation Specialist I 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 an early-career validation professional with hands-on experience executing qualification protocols and documenting results in accordance with cGMP and GDP requirements.

The Validation Specialist will work closely with Quality, Laboratory, Engineering, Manufacturing, and other cross-functional teams to support equipment readiness, protocol execution, discrepancy resolution, and compliant documentation. This is a strong opportunity to gain valuable experience in a highly regulated environment while contributing to critical validation activities for laboratory instruments and equipment.

This position offers exposure to a collaborative, quality-focused workplace with structured procedures, supportive technical teams, and opportunities to strengthen validation, documentation, and pharmaceutical manufacturing knowledge.

Key Responsibilities

- Execute validation and qualification activities for laboratory equipment in accordance with approved protocols, SOPs, cGMP requirements, and regulatory expectations.
- Support IQ, OQ, and PQ activities for laboratory instruments and equipment, including accurate documentation of results and supporting evidence.
- Identify, document, and assist with resolution of discrepancies, deviations, and validation-related issues during protocol execution.
- Review equipment documentation, specifications, manuals, calibration records, and other technical information needed to support validation activities.
- Collaborate with Quality, Laboratory, Engineering, Manufacturing, and cross-functional teams to support equipment commissioning, readiness, and project timelines.
- Maintain validation documentation and records in compliance with Good Documentation Practices and established company procedures.

Compensation and Benefits

- Job type: Contract/Temporary.
- Project duration: Approximately 1 year.
- Work arrangement: On-site.
- Location: Jayuya, Puerto Rico.

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 in English and Spanish, 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, and lift items weighing up to 25 lbs.
- Ability to wear appropriate gowning and PPE in laboratory and manufacturing areas as required.
- Flexibility to work extended shifts depending on project requirements.

Preferred Qualifications

- Experience in the pharmaceutical, biotechnology, medical device, or other regulated industry.
- Prior experience supporting laboratory equipment commissioning or readiness activities.
- Familiarity with validation documentation packages, equipment manuals, calibration records, and technical specifications.
- Experience supporting investigations, corrective actions, or discrepancy resolution related to validation activities.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

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We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.