Top 22 Production process engineer Jobs in Raleigh Durham Nc

Production & Processes Systems Improvement Specialist
Guerbet —Raleigh, NC
- Full-time
- Engineering
- Analysis skills
- Senior level
Plant Process Engineer
CaptiveAire —Wake Forest, NC
- $65,000 - $85,000 a year
- Mid-level
- Assembly
- Ability to lift 50 pounds
- Paid holidays
- Disability insurance
Quick Apply
3d
Plant Process Engineer
CaptiveAire —Youngsville, NC
- $65,000 - $85,000 a year
- Mid-level
- Assembly
- Ability to lift 50 pounds
- Paid holidays
- Disability insurance
Quick Apply
3d
Plant Process Engineer
CaptiveAire —Raleigh, NC
- $65,000 - $85,000 a year
- Mid-level
- Assembly
- Ability to lift 50 pounds
- Paid holidays
- Disability insurance
Quick Apply
3d
Process Engineer / Tech
Micross Components —Durham, NC
- Bachelor of Science
- Mid-level
- Analysis skills
- Health savings account
- Paid holidays
Quick Apply
Wafer Process Engineer (IRSP) 2nd Shift
Micross —Durham, NC
- Bachelor of Science
- Mid-level
- Analysis skills
- Health savings account
- Paid holidays
Quick Apply
Process Engineer / Tech - 2nd Shift
Micross —Durham, NC
- Bachelor of Science
- Mid-level
- Analysis skills
- Health savings account
- Paid holidays
Quick Apply
Senior Manufacturing Systems Engineer – DeltaV Batch
Amgen —Holly Springs, NC
- $136,906.95 - $185,227.05 a year
- On call
- Computer science
- Doctoral degree
- Computer Science
8d
Process Engineer for manufacturing OT (hybrid)
SpiraTec AG —Raleigh, NC
- Online Application
- Hybrid work
- Computer Science
- Mid-level
- Travel
- On-the-job training
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Senior Manufacturing Systems Engineer - PLC Systems
Amgen —Holly Springs, NC
- $136,906.95 - $185,227.05 a year
- On call
- Computer science
- Doctoral degree
- Computer Science
8d
Global Digital Manufacturing Competence Center - Business Process Expert Engineer to Order
Hitachi —Raleigh, NC
- Full-time
- 5 years
- US work authorization
- Business Administration
- Health insurance
- Retirement plan
10d
Quality Engineer
Amphenol TCS —Raleigh, NC
- Microsoft Excel
- 6 years
- Mid-level
Quick Apply
1d
Quality Engineer
Amphenol Communications Solutions —Raleigh, NC
- Microsoft Excel
- 6 years
- Mid-level
1d
Sales Engineer – Manufacturing
Flow Science, Inc. —Chapel Hill, NC
- Mid-level
- 3 years
- Master's degree

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Production & Processes Systems Improvement Specialist

Guerbet -
Raleigh, NC

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Job Details

Full-time

Qualifications

Data integrity assurance
Chemical process control design
Defect resolution root cause analysis
Environmental monitoring in sterile processing
Document control experience within pharmaceutical industry
Cleanroom environmental monitoring
Contamination control
Cleanroom protocols
Sterile field contamination management
Pharmaceutical company experience
Compliance documentation
Regulatory/legal compliance standards in production
Cleanroom experience
Environmental monitoring
Production batch record review
Cross-functional collaboration
Cross-functional communication
FDA regulations
Failure analysis
Pharmaceutical manufacturing facility experience

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The Production & Processes Systems Improvement Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Production & Processes Systems Improvement Specialist is responsible for driving CAPA plan deployment. This role ensures that all required improvements are implemented in a timely, compliant, and sustainable manner. The Specialist is accountable for elevating manufacturing procedures, batch documentation, process controls, and operator practices to align with FDA requirements and industry best practices for facilities producing terminally sterilized pharmaceutical products.

YOUR ROLE

Lead, coordinate, and independently oversee CAPAs originating from system assessments and remediation plans.
Ensure CAPAs are implemented on schedule with sustainable corrective and preventive actions.
Verify CAPA effectiveness through structured follow-up, trending, and objective evidence.
Track remediation progress and escalate delays or barriers to senior leadership.
Remediate and redesign manufacturing SOPs, batch records, work instructions, and in-process controls to enhance compliance.
Implement improvements to line clearance, material flow, equipment status control, and segregation practices across production areas.
Enhance shop floor documentation accuracy, real-time data entry practices, and logbook governance.
Ensure manufacturing processes align with regulatory expectations (e.g., FDA guidance for sterilization, environmental control, and cleanroom operations).
Collaborate with Engineering and Validation to develop or revise process control strategies, equipment parameters, and monitoring requirements.
Provide on-the-floor support to ensure operator practices, gowning, material handling, and data recording meet GMP standards.
Partner with Quality to ensure adherence to data integrity, documentation standards, and change control requirements.
Lead or support investigations into deviations, nonconformances, and process-related issues.
Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field (or equivalent combination of education and experience).
10+ years of experience in pharmaceutical manufacturing operations within GMP-regulated environments.
Extensive hands-on experience with batch record design, manufacturing controls, and process improvement within GMP facilities.
Strong understanding of cleanroom operations and environmental control principles, including classifications, airflow, and contamination control.
Ability to interpret and apply FDA guidance and global regulatory expectations.
Strong analytical, problem-solving, and root cause analysis skills.
Proven cross-functional collaboration, influencing, and communication abilities.
Strong attention to detail with a commitment to data integrity and compliant operations.

Preferred Qualifications

Experience in aseptic or terminal sterilization manufacturing environments.
Deep knowledge of terminal sterilization processes, including pressure cascade, HEPA filtration, and environmental monitoring strategies.
Hands-on experience with aseptic filling operations and airflow visualization (e.g., smoke studies).
Expertise in cleanroom behaviors, aseptic practices, and intervention minimization.
Background in microbiology, sterile operations engineering, or process engineering.
Experience supporting site remediation efforts, regulatory enforcement actions, consent decree environments, or large-scale compliance recovery programs.

Apply Now

Refine Your Search

production process engineer jobs in raleigh durham nc

Production & Processes Systems Improvement Specialist

Plant Process Engineer

Plant Process Engineer

Plant Process Engineer

Process Engineer / Tech

Wafer Process Engineer (IRSP) 2nd Shift

Process Engineer / Tech - 2nd Shift

Senior Manufacturing Systems Engineer – DeltaV Batch

Process Engineer for manufacturing OT (hybrid)

Senior Manufacturing Systems Engineer - PLC Systems

Global Digital Manufacturing Competence Center - Business Process Expert Engineer to Order

Quality Engineer

Quality Engineer

Sales Engineer – Manufacturing

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