Azusa, California, USA
1 day ago
Validation Specialist
Job Title: Validation Specialist
Job Description

We are seeking a detail-oriented Validation Specialist to execute the day-to-day activities of our calibration and validation program, adhering to established procedures, deliverables, and monitoring requirements. The role involves developing, reviewing, and executing validation lifecycle documents for equipment and facilities commissioning as per the validation master plan and internal SOPs. The candidate will also assist in sourcing and implementing electronic CAL/PM systems for equipment management and perform calibration and certification activities.

ResponsibilitiesExecute the calibration and validation program's day-to-day activities, adhering to established functional procedures, deliverables, and monitoring requirements.Develop, review, and execute validation lifecycle documents for equipment and facilities commissioning, as outlined in the validation master plan and internal SOPs (e.g., Validation Plans, Protocols, Reports, URS, Technical Specifications).Assist in sourcing and implementing electronic CAL/PM systems for equipment management.Perform and document calibration and certification activities, coordinating with external vendors when needed.Support GMP facility operations by coordinating validation-related activities.Initiate deviations, conduct investigations, perform impact assessments, and support the development of corrective and preventive actions (CAPAs) and change controls.Assist with the development of risk assessments and support validation activities for product commercialization.Execute cleaning validation and verification processes for facilities as required.Ensure compliance with regulatory requirements, the Validation Master Plan, and internal SOPs during validation activities.Collaborate with facilities and equipment technicians to support maintenance, troubleshooting, and improvements in alignment with production and quality goals.Maintain accurate records for all equipment and systems to ensure ongoing compliance with cGMP standards.Support audits and inspections by regulatory agencies, providing necessary documentation and responses as needed.Essential SkillsBachelor’s degree in engineering, Life Sciences, or a related field.Experience (3-5 years) in validation and calibration within a GMP-regulated industry (beverage, biotech, pharmaceutical, personal care).Working knowledge of GMP regulations and guidelines (e.g., FDA 21 CFR Part 210/211).Familiarity with calibration principles, validation methodologies, and risk-based approaches.Strong organizational and documentation skills, with an eye for detail and quality compliance.Additional Skills & QualificationsExperience performing validations on tanks, fillers, water systems, and cleaning systems.Experience with equipment commissioning, facilities infrastructure, and protocol writing.Work Environment

This position is 100% onsite, with working hours from 8 AM to 5 PM.

Pay and Benefits

The pay range for this position is $80000.00 - $100000.00

Health Insurance: Medical, dental, and vision coverage.
Retirement Plans: 401(k) or other retirement savings plans, often with employer matching.
Paid Time Off (PTO): Vacation days, sick leave, and holidays.
Life Insurance: Basic life insurance policies, sometimes with options to purchase additional coverage.
Disability Insurance: Short-term and long-term disability coverage.
Flexible Work Arrangements: Options for remote work, flexible hours, or hybrid schedules.
Bonuses: Performance-based bonuses, signing bonuses, or referral bonuses.
Professional Development: Opportunities for training, certifications, and continuing education.
Employee Assistance Programs (EAPs): Support services for personal and work-related issues.

Workplace Type

This is a fully onsite position in Azusa,CA.

Application Deadline

This position will be accepting applications until Jan 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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