Validation Specialist I

HR-Work; Jayuya (PR); On-site; USD 52,000 - 70,000; Full time

Job summary

HR-Work in Jayuya, Puerto Rico, seeks a Validation Specialist I to support execution of validation activities for laboratory equipment in a regulated pharmaceutical manufacturing environment. This role involves hands-on validation, documentation, discrepancy resolution, and collaboration with Quality, Laboratory, Engineering, and cross‑functional teams.

The ideal candidate has a Bachelor's degree in Chemistry or Chemical Engineering, at least 1 year of validation experience, knowledge of

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, or related field.
• Minimum 1 year hands-on validation/qualification of laboratory equipment.
• Experience executing validation protocols for laboratory instruments.
• Basic knowledge of IQ, OQ, PQ and cGMP/GDP requirements.
• Ability to document execution, results and supporting evidence with accuracy.
• Strong attention to detail in a regulated environment.

Responsibilities

• Execute validation and qualification activities for laboratory equipment per protocols.
• Support development, review, and completion of validation documentation.
• Perform IQ/OQ/PQ activities and document results with traceability.
• Identify and resolve discrepancies during protocol execution.
• Support investigations and corrective actions as needed.
• Review equipment documentation, specifications, and calibration records.
• Ensure compliance with cGMP, GDP, SOPs and regulatory expectations.
• Collaborate with Quality, Laboratory, Engineering, Manufacturing and cross‑functional teams.

Skills

Documentation

Regulatory compliance

Bilingual English/Spanish

Detail-oriented

Independent work

Education

Bachelor's in Chemistry or Chemical Engineering

Tools

Microsoft Office

Job description

Overview

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.

Location: Jayuya, Puerto Rico
Work Arrangement: On‑Site
Project Duration: Approximately 1 year

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.

Qualifications

• 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.

Physical / Mental Requirements

• Ability to work on‑site in a pharmaceutical manufacturing and laboratory environment.
• Able to stand for extended periods while executing validation or testing activities.
• May require extended working shifts depending on project requirements.
• Able to climb ladders or steps when required.
• Able to lift items weighing up to 25 lbs.
• Must be able to wear appropriate gowning and PPE in laboratory and manufacturing areas as required to comply with GMP and/or OSHA requirements.

We are an equal opportunity employer. We are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected status under applicable law.