Validation Specialist

AppleOne Employment Services

Jayuya (PR)

On-site

USD 34,000 - 62,000

Full time

3 days ago
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Job summary

AppleOne Employment Services is seeking a Validation Specialist for a contract role in Jayuya, Puerto Rico. The position involves executing qualification activities for laboratory equipment, documenting results, and ensuring cGMP compliance in a regulated pharmaceutical setting.

You will support IQ/OQ/PQ activities, develop and review validation documentation, and collaborate with cross-functional teams to ensure equipment readiness throughout a ~1-year project.

Qualifications

  • Bachelor’s degree in Chemistry, Chemical Engineering, or related field.
  • Minimum of 1 year of hands-on validation/qualification experience in regulated industry.
  • Experience executing validation protocols for laboratory instruments.
  • Knowledge of IQ, OQ, PQ concepts.
  • Familiar with cGMP and Good Documentation Practices.
  • Strong attention to detail in a regulated environment.
  • Ability to manage multiple assignments and timelines.
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint).
  • Bilingual in English and Spanish.

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 and related documentation.
  • Perform IQ, OQ, and PQ activities for laboratory instruments and equipment as applicable.
  • Document validation results accurately, including supporting evidence, traceability, discrepancies, and deviations.
  • Collaborate with Quality, Laboratory, Engineering, Manufacturing, and other teams to support equipment readiness and validation deliverables.
  • Participate in project meetings, provide status updates, and manage assigned tasks to meet project timelines and quality expectations.

Skills

Attention to detail
Independent and collaborative
Strong organizational skills
Regulated environment experience

Education

Bachelor’s degree in Chemistry, Chemical Engineering, or related field

Tools

Excel
Word
PowerPoint

Job description

We are seeking a Validation Specialist for a contract opportunity supporting laboratory equipment validation in a regulated pharmaceutical manufacturing environment in Jayuya, Puerto Rico. This role is ideal for an early-career validation professional with hands‑on experience executing qualification protocols and documenting results in compliance with cGMP and Good Documentation Practices.

The Validation Specialist will work on‑site to help ensure laboratory instruments and equipment are properly qualified, documented, and ready for use. This is a strong opportunity to gain valuable pharmaceutical validation experience in a structured, compliance‑focused setting with supportive project leadership, collaborative teamwork, and exposure to critical equipment qualification activities.

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 and related documentation.
  • Perform IQ, OQ, and PQ activities for laboratory instruments and equipment as applicable.
  • Document validation results accurately, including supporting evidence, traceability, discrepancies, and deviations.
  • Collaborate with Quality, Laboratory, Engineering, Manufacturing, and other teams to support equipment readiness and validation deliverables.
  • Participate in project meetings, provide status updates, and manage assigned tasks to meet project timelines and quality expectations.
Compensation and Benefits
  • Pay Rate: $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, preferably in pharmaceutical, biotechnology, medical device, or another 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, SOPs, and validation documentation requirements.
  • Strong attention to detail and ability to work accurately in a regulated environment.
  • Ability to manage multiple assignments, meet timelines, and maintain quality expectations.
  • Strong organizational, analytical, and problem‑solving skills.
  • 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 by GMP and OSHA requirements.
  • Flexibility to work extended shifts depending on project requirements.
Preferred Qualifications
  • Experience supporting validation activities within pharmaceutical manufacturing or laboratory operations.
  • Familiarity with equipment commissioning and readiness activities.
  • Experience supporting discrepancy resolution, investigations, deviations, or corrective actions related to validation execution.
Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here: https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

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.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program: https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

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.

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