Validation Engineer

Actalent; Costa Mesa (CA); Presencial; USD 117.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental

Vision

PTO

Sick time

Holiday Pay

Descripción de la vacante

Actalent is seeking a Senior Validation Engineer for Costa Mesa, CA, to lead hands-on qualification in a sterile pharmaceutical manufacturing environment. You will author IQ/OQ/PQ protocols, execute field validation, and prepare final reports while collaborating with manufacturing, engineering, quality, and operations teams.

The role requires 7+ years of validation experience in a regulated setting, strong technical writing, and the ability to work on the manufacturing floor.

Formación

• Bachelor's degree in Engineering or related technical field.
• 7+ years of validation experience in pharmaceutical or biopharmaceutical manufacturing.
• Experience in sterile/aseptic/injectable environments.
• Hands-on experience executing IQ/OQ/PQ protocols and field validation.
• Strong technical writing and documentation skills.
• Experience qualifying equipment and critical utilities.
• GMP knowledge and regulated manufacturing experience.

Responsabilidades

• Author and execute IQ, OQ, and PQ protocols for pharmaceutical equipment and systems.
• Perform hands-on field qualification activities on the manufacturing floor.
• Review data, analyze results, and prepare final validation reports.
• Investigate discrepancies or deviations during protocol execution.
• Support qualification of equipment like aseptic filling systems, autoclaves, lyophilizers, isolators/RABS, CIP/SIP, sterile filtration.
• Support qualification of utilities including WFI, clean steam, HVAC, compressed air, nitrogen.
• Engage in process and cleaning validation and aseptic manufacturing activities.
• Support changes, deviations, CAPAs, and risk assessments; ensure FDA/cGMP compliance.

Conocimientos

IQ/OQ/PQ

Validation

GMP

Technical writing

Field validation

Sterile manufacturing

Equipment qualification

Risk assessment

Educación

Bachelor's degree in Engineering

Descripción del empleo

Description

We are seeking a Senior Validation Engineer to support validation and qualification activities within a sterile pharmaceutical manufacturing environment. This is a highly hands-on position for an engineer who enjoys being on the manufacturing floor, working directly with equipment and utilities, while also owning the documentation required to support validation activities. The ideal candidate will have strong experience writing and executing IQ/OQ/PQ protocols, troubleshooting issues during execution, reviewing results, and completing final validation reports. This is not a desk-only validation position. The engineer will be actively involved in field execution and work closely with manufacturing, engineering, quality, and other technical teams.

Key Responsibilities

• Author and execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and systems
• Perform hands-on field execution of qualification activities
• Review and analyze test results and prepare final validation reports
• Investigate and document discrepancies or deviations identified during protocol execution
• Support qualification of equipment such as: Aseptic filling systems, Autoclaves, Lyophilizers, Isolators / RABS, CIP/SIP systems, Sterile filtration systems
• Support qualification of critical utilities including WFI, clean steam, HVAC, compressed air, and nitrogen
• Participate in process validation, cleaning validation, and aseptic manufacturing activities
• Support change controls, deviations, CAPAs, and risk assessments
• Maintain validation activities in accordance with applicable FDA/cGMP and global regulatory requirements
• Partner with Engineering, Manufacturing, Quality, and Operations throughout validation projects

What We’re Looking For

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• 7+ years of validation experience within pharmaceutical or biopharmaceutical manufacturing
• Experience working in sterile, aseptic, or injectable manufacturing environments
• Strong hands-on experience executing IQ/OQ/PQ
• Ability to independently write protocols, execute testing, analyze results, and complete reports
• Experience qualifying pharmaceutical manufacturing equipment and/or critical utilities
• Strong technical writing and documentation skills
• Comfortable spending significant time on the manufacturing floor performing validation work
• Working knowledge of GMP requirements and regulated pharmaceutical manufacturing

Skills

• Validation
• Pharmaceutical manufacturing
• Pq
• Oq
• Iq
• Gmp
• Engineering
• Validation protocols
• Process validation
• Pharmaceutical
• Validation testing
• Process engineering
• Manufacturing engineering
• Report writing
• Filling machine
• Aseptic
• Isolators
• SIP
• CIP
• Lyophilizers
• Autoclaves
• Hvac
• Plcs
• Plc troubleshooting
• Automation

Top Skills Details

• Validation
• Pharmaceutical manufacturing
• Pq
• Oq
• Iq
• Gmp

Additional Skills & Qualifications

• Experience qualifying pharmaceutical manufacturing equipment and/or critical utilities
• Strong technical writing and documentation skills
• Comfortable spending significant time on the manufacturing floor performing validation work
• Working knowledge of GMP requirements and regulated pharmaceutical manufacturing

Experience Level

Expert Level

Job Type & Location

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

Pay And Benefits

The pay range for this position is $117000.00 - $130000.00/yr.

• Medical
• Dental
• Vision
• PTO
• Sick time
• Holiday Pay

Application Deadline

This position is anticipated to close on Nov 11, 2026.

Workplace Type

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

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.