Validation Engineer

EQVAL Group, Inc; Juncos (PR); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Life Insurance

Paid time off

Holidays

Professional Growth

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. is seeking Process Engineers with 3+ years in Medical Device or Pharmaceutical manufacturing to execute validation protocols (IQ, OQ, PQ) and optimize processes. The role requires collaboration across cross-functional teams, strong technical writing, and compliance with cGMP standards.

On-site position in Dorado, Puerto Rico. Ideal candidates will have a Bachelor's Degree in Engineering, experience with NCRs, CAPA, LEAN, and Six Sigma tools, and fluency in English and Spanish.

Qualifications

• Bachelor's degree in Engineering required.
• 3+ years of experience in Medical Device or Pharmaceutical industries.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with investigations (NCRs, Complaints, CAPA) and Lean/Six Sigma tools.
• Fully bilingual (English and Spanish) spoken and written.
• Good technical writing skills.

Responsibilities

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation.
• Optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication.
• Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality.
• Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions.
• Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities.

Skills

Validation protocols

Bilingual English/Spanish

Technical writing

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

Lean Manufacturing

Six Sigma

Job description

EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

We are seeking Process Engineers with at least three (3) years of experience in Medical Device or Pharmaceutical industries. The role will focus on executing validation protocols (IQ, OQ, PQ), troubleshooting, and optimizing manufacturing processes.

Responsibilities:

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation
• Optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication
• Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality
• Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions
• Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities
• Bachelor's Degree in Engineering
• Experience in developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ)
• Experience in investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools
• Experience with pFMEA (analysis and development) and its application
• Fully bilingual (English and Spanish) spoken and written
• Good technical writing skills
• Life Insurance
• Paid time off (PTO)
• HolidaysProfessional Growth (Courses and Certifications by EQVAL Academy)
• Referral program
• Productivity incentive

This position will be full-time 100% on site in Dorado, Puerto Rico.

We offer competitive compensation, benefits, and opportunities for career growth. If you are a motivated individual with passion, we would love to hear from you.

EQVAL Group is an EEO. We comply with all federal, local, and state laws regarding non-discrimination.