Validation Specialist II

Curia • Camarillo, CA

3d • $75,000 - $93,000

About The Position

The Validation Specialist II is responsible for developing, reviewing, and
executing validation protocols to support manufacturing and quality operations
while ensuring compliance with regulatory requirements. This role provides
technical expertise and guidance on equipment, component, process, and system
validation activities, collaborating closely with production and quality teams.

Key responsibilities include conducting computer system validations to ensure
adherence to GxP regulations, including 21 CFR Parts 210, 211, and 820, as well
as compliance with Good Automated Manufacturing Practice (GAMP) standards. The
Validation Specialist II ensures that change controls, records, and procedures
align with current Good Manufacturing Practices (cGMP) and regulatory
expectations.

This role also coordinates validation activities with cross-functional teams to
minimize impact on production schedules while ensuring timely execution. The
Validation Specialist II is responsible for authoring validation protocols,
final reports, and technical summaries for the qualification and release of
equipment, systems, instruments, components, and utilities. Additionally, they
may support continuous improvement initiatives and provide mentorship to junior
validation staff.

Curia is a global contract development and manufacturing organization (CDMO)
with over 30 years of experience partnering with pharmaceutical and biotech
companies to provide life-saving treatments to patients. At Curia, we are on a
mission to advance our customers’ therapies from curiosity to cure and
ultimately to improve patients’ lives.

Requirements

• Bachelor’s Degree in Engineering , Microbiology, Sciences, or relevant field of study
• Minimum of three (3) years validation related work experience
• Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance

Responsibilities

• Develops, executes, and reviews validation protocols, including computer system validation, manufacturing equipment qualification including depyrogentation and sterilization equipment, thermal mapping, and lyophilizer qualification
• Authors validation master plans and ensures compliance with regulatory and industry standards
• Conducts and oversees validation testing, analyzing data to assess the accuracy, reliability, and compliance of equipment, systems, instruments, and procedures. Prepares and reviews final reports, recommending adjustments or corrective actions as needed
• Collaborates with cross-functional teams to coordinate validation activities, ensuring timely completion with minimal impact on production schedules
• Provides technical guidance on new equipment, system modifications, and validation best practices
• Supports regulatory compliance by developing and refining validation procedures, recommending policy improvements, and ensuring adherence to FDA, cGMP, GAMP, and EU GMP Annex 11 requirements
• Engages with external vendors and consultants as needed for validation projects
• Provides technical training and support to personnel on validation processes and regulatory expectations
• Performs additional duties as assigned by management, including participation in special projects and continuous improvement initiatives
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising
• Other duties as assigned

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees