Senior Validation Engineer - Lead Hands-On GMP Validation for Critical Pharmaceutical Manufacturing SystemsThis Jobot Job is hosted by: Robert Donohue
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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 DetailsThe 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
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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