Manufacturing Engineer: IQ/OQ/PQ & Process Optimization

EQVAL Group, Inc

Añasco (PR)

On-site

USD 75,000 - 110,000

Full time

2 days ago
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Benefits offered by this job

Life Insurance
PTO
Holidays
EQVAL Academy (Growth)
Referral program
Productivity incentive

Job summary

EQVAL Group, Inc. is seeking a Manufacturing Engineer to lead validation activities (IQ/OQ/PQ) and optimize manufacturing processes for Medical Device and Pharmaceutical projects.

The role emphasizes troubleshooting, regulatory compliance, and collaboration with cross-functional teams to drive efficiency and quality. The position is 100% on-site in Juncos, Puerto Rico, offering competitive compensation, benefits, and growth opportunities through EQVAL Academy.

Qualifications

  • Must have experience validating equipment and processes (IQ/OQ/PQ).
  • Experience with cGMP, FDA inspections, ISO audits, and CAPA.
  • Strong data analysis skills using Minitab.
  • Proficient in English and Spanish.

Responsibilities

  • Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ.
  • Design and optimize manufacturing processes, ensuring efficient layouts and material handling.
  • Troubleshoot and improve production equipment and processes to enhance efficiency and quality.
  • Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and corrective actions.
  • Ensure regulatory compliance (cGMP) in manufacturing and validation activities.

Skills

Validation (IQ/OQ/PQ)
cGMP knowledge
Statistical analysis
MSA/GR&R
DOE
Six Sigma
Bilingual English/Spanish
Minitab

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

EQVAL Group, Inc. is seeking a Manufacturing Engineer to lead validation activities (IQ/OQ/PQ) and optimize manufacturing processes for Medical Device and Pharmaceutical projects.

The role emphasizes troubleshooting, regulatory compliance, and collaboration with cross-functional teams to drive efficiency and quality. The position is 100% on-site in Juncos, Puerto Rico, offering competitive compensation, benefits, and growth opportunities through EQVAL Academy.

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