What are the responsibilities and job description for the Validation Specialist position at Actalent?
Description
• Execute 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 required.
Additional Skills & Qualifications
• Bachelor’s degree in engineering, Life Sciences, or a related field. • Experience (3-5 years) in validation and calibration within a GMP-regulated industry. • 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.
Experience Level
Intermediate Level
Pay and Benefits
The pay range for this position is $38.00 - $50.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Azusa,CA.
Application Deadline
This position will be accepting applications until Jan 25, 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.
Salary : $38 - $50
