Quality Validation Engineer

ActalentLos Angeles, California, USA

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Job Title : Quality Validation Engineer

Job Description

The Quality Validation Engineer is responsible for the validation documentation of equipment, processes, methods, and software, including Master plans, IQ / OQ / PQ, and Final Reports. This role involves executing validation protocols and writing final reports while ensuring adherence to Quality System Regulations and ISO standards. The engineer facilitates improvements and oversees quality control in product design and manufacturing processes. They support R&D and Operations throughout all product development phases, developing process qualification activities, statistically sound sampling plans, and process control plans, including inspection / test method development.

Responsibilities

Create and maintain validation documentation for equipment, processes, methods, and software.
Execute validation protocols and write comprehensive final reports.
Ensure compliance with Quality System Regulations and ISO standards.
Facilitate improvements in quality control product design and manufacturing process control.
Support R&D and Operations during product development phases.
Develop process qualification activities and statistically sound sampling plans.
Design process control plans, including inspection / test method development.

Essential Skills

Proficiency in ISO standards and validation processes.

Effective risk assessment and analysis skills.

Hands-on experience in IQ / OQ / PQ validation and protocol writing.

Knowledge of Cleanroom and Equipment validation.

Experience with Quality Management Systems (QMS).

Familiarity with Minitab and CAPA.

Expertise in root cause analysis and regulatory compliance.

Understanding of automation and GMP practices.

Additional Skills & Qualifications

Bachelor's Degree in a relevant field.

2-5 years of experience in a Quality Validation role.

Experience and knowledge in Good Manufacturing Practices (GMPs) and Quality Systems.

Experience in a regulatory environment (., GMPs, ISO9001, ISO13485).

Experience with validation documentation and executing protocols.

ASQ Certified Quality Engineer preferred.

Pay and Benefits

The pay range for this position is $90000.00 - $110000.00 / yr.

Eligibility to participate in the company discretionary bonus program, subject to personal and company performance;

Eligibility for company 401 (k) defined contribution plan, flexible spending accounts, subject to plan terms and applicable waiting periods;

Eligibility for company paid benefits such as health, dental and vision coverage, life insurance, short and long-term disability, subject to applicable waiting periods;

Paid Time Off (PTO) accrued at a rate equivalent to 120 hours per year; per PTO policy, accruement commences on the date of hire, however, the use thereof are available after 90 days of employment;

Workplace Type

This is a fully onsite position in Los Angeles,CA.

Application Deadline

This position is anticipated to close on Aug 26, 2025.

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Validation Engineer • Los Angeles, California, USA