Manufacturing Process Engineer

abbott; Temecula (CA); On-site; USD 61,300 - 122,700; Full time

Job summary

Abbott is seeking an Experienced Manufacturing Process Engineer in Temecula, CA. This role involves implementing and optimizing manufacturing processes while ensuring compliance with regulations in a highly collaborative environment.

The ideal candidate will hold a Bachelor's Degree and have 3-5 years of process engineering experience, with a strong background in drug delivery systems and a focus on quality systems. Base pay ranges from $61,300 to $122,700.

Qualifications

• Requires a Bachelor's or Master's in Engineering or Science.
• 3 to 5 years of relevant Process Engineering experience.
• Experience with drug delivery systems and manufacturing support.

Responsibilities

• Implement and maintain manufacturing processes.
• Optimize processes and ensure regulatory compliance.
• Conduct tests and measurements throughout production.

Skills

Process Engineering

Manufacturing Support

Six Sigma

Quality Systems

Regulatory Knowledge

Team Collaboration

Education

Bachelor's Degree in Engineering or Science

Tools

cGMP

Risk Analysis Tools

Job description

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This position is located in Temecula, CA.

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.

What You’ll Work On

• 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 determine control over 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.

Required Qualifications

Education

• Bachelor's Degree (± 16 years) in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or Science.

Experience

• Minimum 3 to 5 years of Process Engineering or Operations experience with a Bachelor's Degree, or a Master's Degree plus 3 years of Process Engineering or Operations experience.
• Process/equipment development and optimization experience in small drug molecules and polymer‑based drug delivery systems.
• Knowledge of late‑stage or commercial products 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.

Compensation and Work Conditions

The base pay for this position is $61,300.00 – $122,700.00.

Job Family: Engineering.

Division: AVD Vascular.

Location: United States > Temecula: Building E - TE.

Work Shift: Standard.

Travel: Not specified.

Medical Surveillance: Not Applicable.

Significant Work Activities: Continuous sitting, standing, walking for prolonged periods, and work in a clean‑room environment.

EEO Statement

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law: English: http://webstorage.abbott.com/common/External/EEO_English.pdf, Español: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf.