Manufacturing Process Engineer

Abbott • Temecula, CA

3d • Onsite

About The Position

Experienced Manufacturing Process Engineer that works under limited supervision. Applies subject matter knowledge in the area of Medical Device and Manufacturing Engineering. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. This position works out of our Temecula, CA location in the Abbott Vascular Devices division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Requirements

• Bachelors Degree (± 16 years) Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or Science
• Minimum 3 year Bachelor's Degree 3-5 years of Process Engineering or Operations experience OR a Master's Degree + 3 years of Process Engineering or Operations experience.
• Process/equipment development and optimization experience in small drug molecules and polymers based drug delivery systems.
• Knowledge of late stage or commercial products experience with strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
• Strong knowledge of Quality systems, drug product manufacturing and process validation.
• Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.

Responsibilities

• Possesses well developed skills in implementing and maintaining pharmaceutical/biological processes.
• Calculates and organizes all data for complex process flow sheets including instrumentation and control considerations.
• Models processes and units operations.
• Ensures proper sequence of operation and prepares specifications and operating instructions for processing equipment.
• Conducts tests and measurements throughout stages of production to control variables such as temperature, density, pressure and viscosity.
• Services, troubleshoots, and solves engineering problems with processes or equipment already in operation.
• Ensures processes and procedures are in compliance with regulations.
• May be responsible for corrective and preventive actions and investigation management.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level