Location: Anasco, PR

Job Purpose:

To plan, develop, and implement documentation, procedures, and training to support engineering, production, and quality teams. The role is primarily focused on the validation of processes, equipment, systems, and facilities, ensuring compliance with internal procedures and regulatory standards (FDA, ISO, GMP, etc.). The Validation Engineer will lead and support cross-functional projects, provide statistical analysis, and recommend quality/process improvements.

Responsibilities:

• Develop and implement documentation, procedures, and training for engineering, production, and quality personnel.
• Generate and execute change controls, validation plans, validation protocols (FAT, SAT, IQ, OQ, PQ, CSVs), and completion reports.
• Provide statistical analysis to support validation and quality reports.
• Develop statistically based sampling plans for in-process/final testing, inspections, and validations.
• Review and approve validation documents and completion reports for new and existing products, processes, and equipment.
• Troubleshoot equipment/process performance issues during validation runs.
• Recommend process and quality improvements identified during validations.
  • Conduct validations on equipment, processes, utilities, facilities, and cleaning procedures, including but not limited to:
  • Packaging equipment (e.g., Multivac)
  • Freeze-drying, CCA
  • DIUF, RO/DI, WFI, Pure Steam, SIP Systems
  • HEPA filters, chillers, temperature units, lab equipment
• Investigate and document non-conformances and protocol deviations.
• Maintain effective working relationships with internal teams (Manufacturing, Engineering, Regulatory, Quality Assurance) and external vendors/customers.
• Ensure compliance with regulatory/international standards such as FDA, ISO, OSHA, and EPA.
• Participate in or lead cross-functional project teams.
• Perform other duties as assigned.

Qualifications:

• Education: Bachelor’s degree in Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical) or a science-related discipline.
• Certifications: Lean/Six Sigma Green or Black Belt certification is a plus.
• Experience:
  • 5–7 years of experience in medical device and/or pharmaceutical manufacturing.
  • Minimum of 5 years specifically in a validation engineering role.

• Technical Knowledge:

  • Experience in various types of validations: packaging, manufacturing, lab equipment, cleaning, test methods, computer systems, shipping, shelf life, sterilization, facilities, clean rooms, and utilities (HVAC, compressed air, water systems).
  • Knowledge of packaging components and equipment is highly desirable.
  • Familiarity with FDA, BSI, OSHA, EPA, GMP, and ISO requirements.

• Skills:

  • Strong strategic thinking and project leadership skills.
  • Ability to lead teams and collaborate cross-functionally.
  • Excellent communication skills.
  • Skilled in developing technical documentation (e.g., change controls, validation plans, protocols, investigation reports, SOPs).
  • Organizational excellence and knowledge of Lean/Six Sigma principles.

• Other Requirements:

  • Team-oriented, proactive self-starter.
  • Fully bilingual (Spanish/English).
  • Available to work extended shifts or non-working days as required.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $58.98/hr.