Process Engineer

Job Title: Process EngineerJob 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. 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 View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent