Validation Engineer

EQVAL; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid time off (PTO)

Holidays

EQVAL Academy courses

Job summary

EQVAL Group, Inc. is seeking Process Engineers with at least three years of experience in Medical Device or Pharmaceutical industries. The role focuses on executing validation protocols (IQ, OQ, PQ), troubleshooting, and optimizing manufacturing processes. On-site, Dorado, Puerto Rico.

The position requires a Bachelor's degree in Engineering and experience with validation documents, NCRs/Complaints, CAPA, Lean, and Six Sigma tools. Bilingual in English and Spanish is essential.

Qualifications

• Bachelor's degree in Engineering required.
• Experience with validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with NCRs, Complaints, CAPA, Lean Manufacturing, and Six Sigma tools.
• Familiarity with pFMEA and its application.
• Fully bilingual in English and Spanish, spoken and written.

Responsibilities

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

Skills

Bilingual English/Spanish

Technical writing

NCRs/Complaints investigations

Process improvement

Problem solving

Education

Bachelor's degree in Engineering

Tools

pFMEA

LEAN Manufacturing

Six Sigma tools

Validation Plans/IQ/OQ/PQ

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.

Minimum Requirements:

• 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.

Benefits:

• Health insurance (Medical, Dental, Vision, Pharmacy)
• Life Insurance
• Paid time off (PTO)
• Holidays
• Professional 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.