The Role
Support daily manufacturing operations for medical device and pharma processes, including validation lifecycle (design/execute/analyze/close), root cause analysis, investigations and QN/CAPA closures, and working with manual and automated production lines. Provide operational support across shifts in a fast-paced, 24/7 site in Texas. Bilingual (English/Spanish) required.
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 Engineering (Mechanical, Chemical, Industrial, Biomedical, or related)
- Strong experience in the Medical Device industry
- Pharmaceutical industry experience
- Demonstrated experience with validation life cycle activities (design, execute, analyze, 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
- Flexible to support 24/7 operation including shifts, weekends, and holidays
- Bilingual in English and Spanish
- 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.
