Process Engineer

Process EngineerWe 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.ResponsibilitiesInvestigate 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 SkillsBachelor'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 & QualificationsIV 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 EnvironmentThe work environment is a high-volume medical device and pharmaceutical manufacturing setting.Job Type & LocationThis is a Contract to Hire position based out of Irvine, CA.Pay and BenefitsThe 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 TypeThis is a fully onsite position in Irvine, CA.Application DeadlineThis position is anticipated to close on Aug 25, 2026.