Process Engineer

Actalent; California (MO); On-site; USD 59,000 - 73,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

Employee Assistance Program

Paid time off

Job summary

Actalent is seeking a Process Engineer for a pharmaceutical IV bag production operation in Irvine, CA. The role focuses on investigating events, leading root cause analyses, supporting CAPA activities, and optimizing processes to improve quality and efficiency.

You will collaborate with Quality, Operations, Maintenance, and Validation to ensure GMP compliance and effective changes across filling, welding, printing, labeling, and packaging lines.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 3+ years pharma manufacturing or 5+ years regulated manufacturing.
• Experience leading CAPA investigations and root cause analyses.
• Experience with deviation management and non-conformance investigations.
• Experience supporting GMP-regulated manufacturing environments.
• Strong statistical and data analysis skills.
• Proven ability to address manufacturing floor issues and implement solutions.

Responsibilities

• Investigate deviations, non-conformances, customer complaints, and manufacturing process failures.
• Conduct root cause analyses utilizing tools such as 5-Why, Fishbone, and statistical analysis techniques.
• Support CAPA development, implementation, effectiveness verification, and closure activities.
• Analyze production data to identify trends, process gaps, and improvement opportunities.
• Support and optimize manufacturing processes including filling, welding, printing, labeling, and packaging operations.
• Develop and implement process improvements to enhance yield, quality, throughput, and cost performance.
• Participate in change control, process validation, and equipment qualification activities (IQ/OQ/PQ).
• Ensure compliance with GMP requirements and company quality standards.
• Collaborate with cross-functional teams including Quality, Operations, Maintenance, and Validation.

Skills

CAPA investigations

Root cause analysis

GMP manufacturing

Data analysis

Process optimization

Education

Bachelor's degree in engineering

Job description

Job Description

Job Title: Process Engineer

Job Description

We are seeking a Process Engineer to support a pharmaceutical manufacturing operation focused on IV bag production. This individual will be responsible for investigating manufacturing and quality events, leading root cause analyses, supporting CAPA activities, optimizing manufacturing processes, and implementing corrective actions that improve product quality and operational performance.

Responsibilities

• Investigate deviations, non-conformances, customer complaints, and manufacturing process failures.
• Conduct root cause analyses utilizing tools such as 5-Why, Fishbone, and statistical analysis techniques.
• Support CAPA development, implementation, effectiveness verification, and closure activities.
• Analyze production data to identify trends, process gaps, and improvement opportunities.
• Support and optimize manufacturing processes including filling, welding, printing, labeling, and packaging operations.
• Develop and implement process improvements to enhance yield, quality, throughput, and cost performance.
• Participate in change control, process validation, and equipment qualification activities (IQ/OQ/PQ).
• Ensure compliance with GMP requirements and company quality standards.
• Collaborate with cross-functional teams including Quality, Operations, Maintenance, and Validation.

Essential Skills

• Bachelor's Degree in Engineering or related technical discipline.
• 3+ years of pharmaceutical manufacturing experience OR 5+ years of manufacturing engineering experience in a regulated industry.
• Experience leading CAPA investigations and root cause analyses.
• Experience with deviation management and non-conformance investigations.
• Experience supporting GMP-regulated manufacturing environments.
• Strong statistical and data analysis skills.
• Proven ability to address manufacturing floor issues and implement solutions.

Additional Skills & Qualifications

• IV bag manufacturing experience.
• Plastics manufacturing experience.
• Experience with syringe or disposable medical device manufacturing.
• Cleanroom filling experience.
• RF welding or thermal welding process experience.
• Lean Manufacturing and Continuous Improvement experience.
• Process validation and qualification experience.
• FMEA and risk assessment experience.

Work Environment

The work environment is a high-volume medical device and pharmaceutical manufacturing setting.

Job Type & Location

This is a Contract to Hire position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $43.00 - $53.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Aug 25, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email