The Role
Process Engineer supporting pharmaceutical and medical device manufacturing operations. Responsibilities include validation lifecycle activities, root cause analysis, QN and CAPA investigations and closures, and support for manual and automated production systems. The role requires a bachelor’s degree in engineering, medical device experience, bilingual English and Spanish skills, and flexibility to support 24/7 operations, including shifts, weekends, and holidays, in Texas.
Summary Generated by Built In
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
Requirements
- 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.
Skills Required
- Bachelor’s degree in Mechanical, Chemical, Industrial, Biomedical, or related Engineering field
- Strong experience in the medical device industry
- Pharmaceutical industry experience
- Experience with validation lifecycle activities, including designing, executing, analyzing, and closing protocols and reports
- Experience performing root cause analysis and implementing solutions
- Experience supporting investigations, QN, and CAPA closures
- Experience with manual and automated manufacturing systems or production lines
- Ability to work effectively in a fast-paced manufacturing environment
- Ability to support 24/7 operations, including shifts, weekends, and holidays
- Bilingual English and Spanish proficiency
- Availability to work in Texas
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
