Senior Validation Engineer

Jobot; Costa Mesa (CA); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Competitive salary up to $125K

Own critical validation programs

Work with GMP manufacturing equipment

Visible role in Quality andManufactur­

Growth opportunities in a regulated环境

Job summary

Jobot is hiring a Senior Validation Engineer to lead hands-on GMP validation for critical pharmaceutical manufacturing systems in Costa Mesa, CA. The role focuses on protocol development, execution, and final reporting, with substantial hands-on equipment work and calibration oversight.

The ideal candidate will develop IQ/OQ/PQ protocols, validate equipment and processes, and ensure compliance with GMP. Autoclave and sterilization validation experience is highly desirable.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Hands-on validation experience in GMP manufacturing.
• Experience developing IQ/OQ/PQ protocols and documenting results.
• Strong GMP understanding and quality documentation skills.

Responsibilities

• Develop, execute, and document equipment and process validation protocols.
• Establish validation standards, testing procedures, acceptance criteria, and final reports.
• Perform hands-on validation of manufacturing equipment and systems.
• Validate sterilization cycles and autoclaves; support cleanroom validation.
• Create SOPs, protocols, and GMP documentation; participate in audits.
• Maintain calibration records and support Change Control activities.

Skills

Hands-on validation

IQ/OQ/PQ protocols

Equipment validation

Process validation

GMP knowledge

Technical writing

MS Office proficiency

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kaye Validation System

Job description

Job details

Senior Validation Engineer – Lead Hands-On GMP Validation for Critical Pharmaceutical Manufacturing Systems

This Jobot Job is hosted by: Robert Donohue

Salary: $115,000 - $125,000 per year

A bit about us

We are a growing life sciences organization focused on delivering high-quality products within a highly regulated GMP manufacturing environment. Our team is committed to quality, compliance, continuous improvement, and maintaining validation standards across critical manufacturing equipment, processes, utilities, and systems.

We are seeking an experienced Senior Validation Engineer who brings strong hands-on validation experience and can take ownership of validation activities from protocol development through execution, documentation, and final reporting.

Why join us

• Competitive salary up to $125K
• Opportunity to own critical validation programs
• Work with sophisticated pharmaceutical manufacturing equipment and systems
• Highly visible role within Quality and Manufacturing
• Exposure to equipment, process, utility, sterilization, and computerized system validation
• Collaborative environment with opportunities for continued professional growth
• Make a direct impact on GMP compliance and product quality

Job Details

The Senior Validation Engineer will design, execute, and maintain validation programs supporting GMP manufacturing operations. This position requires someone who is comfortable being hands-on with equipment and validation activities, not simply reviewing documentation.

The ideal candidate will have experience developing and executing IQ/OQ/PQ protocols, performing equipment and process validation, supporting sterilization systems, and ensuring manufacturing systems remain compliant with applicable GMP requirements.

Experience working with autoclaves, lyophilizers, and Grade A/Class 4 or 5 cleanroom environments is highly desirable.

Responsibilities

• Develop, execute, and document equipment and process validation protocols, including IQ/OQ/PQ
• Establish validation standards, testing procedures, acceptance criteria, and final validation reports
• Perform hands-on validation and qualification of manufacturing equipment and systems
• Perform annual revalidation of steam and dry-heat sterilizers using Kaye validation systems
• Develop new sterilization cycles as required
• Support validation of autoclaves and lyophilization equipment
• Perform periodic evaluations of manufacturing and laboratory equipment
• Implement and maintain the Validation Master Plan for equipment and processes
• Validate critical utility and facility systems, including water systems and air-handling units
• Support validation activities within controlled cleanroom environments
• Maintain equipment calibration records and perform calibration activities as required
• Conduct risk-based assessments and validation of 21 CFR Part 11 systems
• Support Change Control activities and associated validation requirements
• Create and maintain SOPs, protocols, reports, and other GMP documentation
• Participate in internal and external audit activities
• Identify equipment or process deficiencies and recommend corrective actions
• Support preventive, general, and facility maintenance activities through appropriate work orders
• Ensure equipment and systems operate within approved specifications and regulatory requirements

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
• Strong hands-on validation experience within a GMP-regulated manufacturing environment
• Experience developing and executing IQ/OQ/PQ protocols
• Equipment and process validation experience
• Strong understanding of GMP requirements and validation practices
• Experience developing protocols, documenting testing results, and writing final validation reports
• Strong technical writing and documentation skills
• Experience with Microsoft Word, Excel, PowerPoint, and related applications
• Ability to work 100% onsite in Costa Mesa, CA

Preferred Qualifications

• Hands-on autoclave validation experience
• Experience with lyophilizers / lyophilization equipment
• Experience working in Grade A/Class 4 or Class 5 cleanroom environments
• Kaye Validation System experience
• Steam and dry-heat sterilization validation experience
• Clean utilities, water systems, and HVAC/AHU validation
• Calibration experience
• 21 CFR Part 11 validation experience
• Pharmaceutical, biotechnology, or other regulated life sciences manufacturing experience

Equal Opportunity

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

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