Title: Process Engineer
Location: Plano, TX
Duration: 12 Month
100% Onsite
Job Summary:
We are seeking a highly motivated and detail-oriented Process/Manufacturing Engineer to support our production operations and continuous improvement initiatives. The ideal candidate will have experience in process validation, equipment qualification, risk analysis, and production line support within a regulated environment such as medical devices, biotech, or pharmaceuticals.
Key Responsibilities:
- Perform equipment qualification (IQ, OQ, PQ, PPQ) to ensure compliance with regulatory and quality standards.
- Conduct process characterization and analyze key performance metrics.
- Lead and support non-production software validation activities.
- Plan and execute process validation protocols and reports.
- Develop and maintain process risk documentation (PFMECA).
- Provide manufacturing line support during production builds to troubleshoot issues and optimize performance.
- Assist in material tracking and generate purchase requests (PRs) to support operations.
- Support the development and validation of test methods and inspection procedures.
Key Skills & Qualifications:
- Bachelor's degree in Engineering (preferably Biomedical, Mechanical, Electrical, or Software).
- 5+ years of experience in process or manufacturing engineering roles.
- Strong knowledge of validation protocols (IQ/OQ/PQ/PPQ).
- Experience with PFMECA, process risk analysis, and documentation in regulated industries.
- Proven track record in manufacturing line support, process troubleshooting, and continuous improvement.
- Excellent organizational, problem-solving, and communication skills.
- Ability to work collaboratively with cross-functional teams.
Preferred Experience:
- Background in medical devices, biotech, pharmaceuticals, or other GMP-regulated environments.
- Hands-on experience with new process introductions and sustaining manufacturing operations.
Consultants Eligible Benefits Upon Waiting Period:
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.