Validation Specialist II

Validation Specialist II in Camarillo, CA

Build your future at Curia, where our work has the power to save lives

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.

We proudly offer

* 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!

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

Required

* 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

Other Qualifications

* Must pass a background check

* Must pass a drug screen

* May be required to pass Occupational Health Screening

* May be required to obtain and maintain gowning certification

* May be required to obtain and maintain media qualification

Pay Range: $75,000-$93,500/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia.

No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal…