Process Engineer

QRC Group, Inc; San Juan (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

QRC Group, LLC, a firm serving the Pharma, Medical Devices and Chemical industries in validation and regulatory fields, seeks a Process Engineer with pharma/medical device experience and validation lifecycle expertise to support daily operations.

The role requires root cause analysis, CAPA closures, and experience with both manual and automated manufacturing lines in a fast-paced environment; bilingual English/Spanish is required; availability to work in Texas is needed.

Qualifications

• Bachelor's degree in engineering required.
• Strong experience in the Medical Device industry.
• Pharmaceutical industry experience preferred.
• Experience with validation life cycle activities.
• Experience supporting investigations, QN and CAPA closures.
• Experience working with manual and automated manufacturing systems.

Responsibilities

• Root cause analysis and implementation of solutions.
• Investigations and CAPA closures (QN/CAPA).
• Support both manual and automated manufacturing lines in a fast-paced environment.

Skills

Root cause analysis

CAPA investigations

Validation life cycle

Manual and automated manufacturing

Bilingual English/Spanish

Pharma/Medical device experience

Education

Bachelor's Degree in Engineering

Job description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:

• Root cause analysis
• Investigation experience for QN/CAPAclosures
• Experience with manual and automated systems/lines

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
• Strong experience in the Medical Device industry (required).
• Pharmaceutical industry experience (preferred).
• Demonstrated experience with validation life cycle activities (design, execute, analyze, and close protocols/reports).
• Experience performing root cause analysis and implementing solutions.
• Experience supporting investigations, QN, and CAPA closures.
• Experience working with manual and automated manufacturing systems/production lines.
• Ability to work effectively in a fast-paced manufacturing environment.
• Standard site schedule; flexible to support 24/7 operation including shifts, weekends, and holidays as operational demands requireBilingual (English and Spanish) required.
• Availability to work in Texas.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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