Reliability Engineer

This onsite role is pivotal in managing the work order system, coordinating facility drawings, and engineering and maintenance schedules. The Reliability Engineer authors deviations, CAPAs, and change controls, serving as the Quality Systems owner for the Facilities and Engineering function, and collaborates cross-functionally on investigations and corrective actions.

Responsibilities

• Coordinate Facilities and Engineering schedules across engineering projects, preventive maintenance, calibration activities, and plant shutdowns.
• Own the CAPA, deviation, and change control processes from creation to closure, including investigation, root cause analysis, and effectiveness verification.
• Author technical documentation including deviation investigations, CAPAs, SOPs, protocols, and reports in compliance with cGDP requirements.
• Serve as the Quality Systems owner for the Facilities and Engineering function, ensuring documentation, records, and processes meet FDA regulatory expectations.
• Administer the CMMS (Computerized Maintenance Management System), including work order planning, scheduling, execution monitoring, and reporting.
• Manage facility drawings, including maintenance and editing using CAD software.
• Support validation executions, including temperature mapping of TCUs (Temperature Control Units), as needed.
• Accurately perform and record readings of various equipment across the site.
• Manage external vendors and contractors for preventive maintenance scheduling, on-site coordination, and work completion verification.
• Prepare and present maintenance, validation, and calibration reports for monthly and quarterly business reviews.
• Collaborate cross-functionally on investigations and cross-functional CAPA activities.
• Perform other duties as assigned.

• 5 years of experience in maintenance planning and/or technical writing within an FDA-regulated manufacturing environment.
• Thorough working knowledge of CAPA, deviation, and change control processes, including investigation and root cause methodology.
• Demonstrated technical writing proficiency across deviations, CAPAs, SOPs, and validation documentation.
• Working knowledge of cGDPs (current Good Documentation Practices).
• Hands-on experience administering a CMMS, including work order planning, scheduling, and monitoring.
• Proficiency with CAD software for facility drawing maintenance and editing.
• Experience supporting validation activities, including temperature mapping of TCUs.
• Ability to manage vendors and contractors for PM-related work.
• Strong written and verbal communication skills, including the ability to present technical reports to leadership.
• Ability to work onsite full-time in Costa Mesa, CA.

• Bachelor's Degree in Engineering field.
• 5-10 years experience in manufacturing setting.
• 3 years quality systems experience.
• Experience in Pharma, Biotech, or Mechanical Device industry.
• Familiarity with reliability engineering, manufacturing engineering, facility layout, and facilities equipment.
• Experience with capex, design, quality control, maintenance, GMP, cGMP, technical writing, SOP, deviations, and facilities maintenance.
• Experience with SolidWorks and AutoCAD.
• Experience with root cause failure analysis.
• Experience with MasterControl or similar QMS systems.
• Exposure to validation activities.
• Experience supporting equipment or production line startup/expansion.
• Familiarity with regulated manufacturing equipment environments.

Work will be conducted in a pharmaceuticals manufacturing facility.

Job Type & Location

This is a Permanent position based out of Costa Mesa, CA.

The pay range for this position is $120000.00 - $145000.00/yr.

Benefits include but are not limited to: Medical Dental Vision PTO, Sick time and Holiday pay Additional employee benefits available upon request

This is a fully onsite position in Costa Mesa,CA.

This position is anticipated to close on Jun 22, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccommodation@actalentservices.com 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.

Salary : $120,000 - $145,000