Manufacturing Engineer - Pharmaceutical

Actalent; Irvine (CA); On-site; USD 59,237,000 - 73,013,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

HSA

Commuter benefits

PTO

Job summary

The Mechanical Engineer will support high-volume IV bag manufacturing with hands-on maintenance, design, and process optimization in a GMP environment. Responsibilities include equipment troubleshooting, CAPA support, and validating equipment with IQ/OQ/PQ, while collaborating across Quality, Operations, and Maintenance teams.

Ideal candidates have 3+ years in pharma manufacturing or 5+ years in regulated industries, with strong SolidWorks and AutoCAD skills and a focus on reliability and

Qualifications

• Bachelors degree in mechanical engineering or closely related field.
• 3+ years in pharmaceutical manufacturing or 5+ years in regulated manufacturing engineering.
• 2+ years hands-on troubleshooting of production equipment.
• Strong design skills with SolidWorks and AutoCAD.
• Experience with root cause investigations and CAPA activities.
• Familiarity with GMPs and validation (IQ/OQ/PQ).

Responsibilities

• Support IV bag manufacturing processes including welding, filling, labeling, and automated packaging systems.
• Lead equipment troubleshooting to resolve mechanical, automation, and process issues.
• Conduct root cause investigations and document findings.
• Assist CAPA investigations and implement corrective actions.
• Design modifications and tooling using SolidWorks and AutoCAD.
• Improve OEE and reduce scrap through continuous improvement.
• Support equipment qualification and validation activities (IQ/OQ/PQ).
• Participate in change control processes and GMP compliance.
• Analyze performance data to identify trends and risks.
• Collaborate with Quality, Operations, Maintenance, and Technical Services.

Skills

SolidWorks

AutoCAD

GMP knowledge

Root cause analysis

Troubleshooting

Equipment reliability

Education

Bachelor's Degree in Mechanical Engineering

Job description

Job Title: Mechanical Engineer – Pharmaceutical Manufacturing

Job Description

This role supports high-volume pharmaceutical manufacturing operations focused on IV bag production. The Mechanical Engineer provides hands‑on support for automated manufacturing equipment, tooling, filling systems, welding operations, and packaging processes, while driving equipment reliability, quality improvements, and process optimization in a GMP‑regulated environment.

Responsibilities

• Support IV bag manufacturing processes, including welding, filling, printing, labeling, and automated packaging systems.
• Lead equipment troubleshooting activities to quickly resolve mechanical, automation, and process issues impacting production.
• Conduct root cause investigations for quality issues, downtime events, and production inefficiencies, and document findings in a structured manner.
• Support CAPA investigations and implement effective corrective and preventive actions to prevent recurrence of issues.
• Design and implement equipment modifications, mechanical improvements, and new tooling solutions using SolidWorks and AutoCAD.
• Improve equipment performance, reliability, and overall equipment effectiveness (OEE) to increase throughput and reduce scrap.
• Support validation and equipment qualification activities, including IQ, OQ, and PQ, in accordance with quality and regulatory requirements.
• Participate in change control processes for equipment and process changes, ensuring compliance with internal procedures and GMP standards.
• Analyze process and equipment performance data to identify trends, risks, and opportunities for continuous improvement.
• Collaborate closely with Quality, Operations, Maintenance, and Technical Services teams to resolve issues and deliver robust manufacturing solutions.
• Ensure all engineering activities align with GMP requirements, company quality systems, and applicable regulatory standards.
• Contribute to preventive maintenance strategies and reliability engineering efforts to minimize unplanned downtime.
• Apply risk assessment tools such as FMEA to evaluate process and equipment changes and propose risk mitigation actions.
• Support automation and machine design initiatives to enhance manufacturing capabilities and support new or improved products.
• Provide technical support for filling equipment, packaging equipment, and cleanroom manufacturing operations.

Essential Skills

• Bachelor's Degree in Mechanical Engineering or a closely related discipline.
• 3+ years of pharmaceutical manufacturing experience OR 5+ years of manufacturing engineering experience in a regulated industry.
• 2+ years of hands‑on experience troubleshooting manufacturing equipment in a production environment.
• Proficiency with SolidWorks for mechanical design, modeling, and tooling development.
• Experience using AutoCAD for equipment layouts, drawings, and design updates.
• Demonstrated experience supporting root cause investigations and CAPA activities.
• Strong understanding of mechanical systems, including pneumatics, heat transfer, tooling, and high‑volume manufacturing processes.
• Experience working within GMP‑regulated manufacturing environments, such as medical device or pharmaceutical facilities.
• Experience with equipment qualification and validation activities, including IQ, OQ, and PQ.
• Proven ability to analyze equipment and process performance data to drive continuous improvement.
• Familiarity with risk assessment methodologies such as FMEA and related tools.
• Experience with preventive maintenance and reliability engineering concepts in a production setting.

Additional Skills & Qualifications

• Experience in IV bag manufacturing or similar fluid packaging operations.
• Plastics manufacturing experience, particularly in forming and sealing applications.
• Hands‑on experience with thermal welding or RF welding processes for flexible packaging or plastic components.
• Cleanroom manufacturing environment experience, ideally in medical device or pharmaceutical production.
• Direct experience with filling equipment used in liquid or sterile manufacturing processes.
• Experience with automated packaging equipment in a high‑volume production setting.
• in automation and machine design to support new equipment or upgrades.
• Lean Manufacturing and Continuous Improvement experience, including implementation of process improvements on the shop floor.
• Experience performing formal risk assessments and contributing to FMEA activities.
• Exposure to reliability engineering practices to enhance equipment uptime and performance.
• Strong mechanical design skills with the ability to develop and refine tooling and fixtures for production.
• Ability to work effectively in cross‑functional teams, including Quality, Operations, Maintenance, and Technical Services.

Work Environment

The role is based in a high-volume pharmaceutical and medical device manufacturing environment focused on IV bag production. The facility operates multiple fully automated manufacturing lines capable of producing a very high number of units per minute, requiring strong attention to detail, safety, and quality. Work takes place in regulated, GMP‑compliant production areas, which may include cleanroom environments with defined gowning and hygiene protocols. The engineer works closely with production, maintenance, quality, and technical teams on the manufacturing floor, frequently interacting with automated equipment, filling systems, welding stations, and packaging lines. The environment emphasizes continuous improvement, reliability, and efficiency, supported by modern engineering tools such as SolidWorks and AutoCAD, and structured validation and risk management practices

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.

• 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 Sep 18, 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 [e-mail] 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.