Validation Engineer II – Quality/Regulatory (2568)

Validation Engineer II – Quality/Regulatory
Contract Duration: 1 year
Pay Rate: $35–$45 per hour
Location Requirement: Candidate must live in Puerto Rico (no relocation or travel expenses).

Summary:
The Validation Engineer II will support engineering operations by executing equipment, process, and computerized systems validation activities. This role will directly support the installation, construction, startup, and validation of new lyophilizer (Lyo) equipment and a new industrial chiller, as well as facility systems such as compressed air, chillers, and HVAC. Medical device or pharmaceutical experience is highly preferred.

Key Responsibilities:

• Develop and maintain validation documentation, procedures, and training.

• Execute the full Validation Life Cycle: requirements definition, risk assessments, traceability, protocol development, testing, and reporting.

• Generate URS, FRS, SDS, validation plans, traceability matrices, and IQ/OQ/PQ protocols.

• Perform statistical analysis and develop sampling plans for testing and inspections.

• Review, approve, and troubleshoot validation activities for equipment, process, computer, and automation systems.

• Investigate deviations, non-conformances, and complete CAPA documentation and reports.

• Support the installation, startup, and qualification of Lyo and chiller systems.

• Coordinate with vendors on procurement, schedules, installation, training, and technical deliverables.

• Provide validation metrics, trending charts, and operational review reports.

• Collaborate with Manufacturing, Engineering, Quality, and Regulatory teams.

• Participate in internal and external audits (FDA, BSI, Corporate).

• Ensure compliance with FDA, ISO, OSHA, EPA, GMP, GAMP 5, and internal quality standards.
  
  

Education & Experience:

• Bachelor’s degree in Mechanical, Industrial, Electrical, Chemical, Biomedical Engineering or related science discipline.

• 4–6 years of experience in equipment, process, and CSV validation.

• Strong knowledge of FDA, ISO, GMP, GAMP 5, and CSV lifecycle methodologies.

• Experience generating and executing URS, FRS, SDS, validation plans, IQ/OQ/PQ protocols, and reports.

• Understanding of test strategies, system architecture, and defect detection methods.

• Strong project management, communication, and problem-solving skills.

• Ability to prepare technical documentation such as SOPs, Change Controls, investigations, and technical reports.

• Experience working cross-functionally and coordinating with external vendors.

• Team-oriented, self-starter, and fully bilingual (English/Spanish).
  
  

Preferred Experience:

• Installation, construction, and validation of lyophilizer (Lyo) systems, including process validation.

• Installation, procurement, and validation of industrial chillers.

• Experience with facility systems: compressed air, chillers, HVAC.

• Prior experience in medical device or pharmaceutical industries.