Senior Validation Operations Specialist
4 weeks ago
Responsibilities:
Develop and execute validation protocols for analytical equipment, including IQ/OQ/PQ, to ensure regulatory compliance and performance specifications.
Ensure that all validation activities align with FDA, GMP, and ISO standards, and perform risk assessments and impact analyses for new and existing equipment.
Coordinate with cross-functional teams to support equipment commissioning and qualification, and prepare and review validation documentation, including validation plans, protocols, and reports.
Troubleshoot and resolve equipment-related issues to ensure continuous compliance and operation, and maintain detailed and accurate records of validation activities.
Train and mentor staff on validation procedures and best practices, and stay updated with industry trends and advancements in validation technology.
Requirements:
A Bachelor's degree in Engineering, Life Sciences, or a related field, and proven experience in validation of analytical equipment within a GMP-regulated environment.
Strong knowledge of validation principles and regulatory requirements, including FDA, GMP, and ISO standards, and proficiency in developing and executing IQ/OQ/PQ protocols.
Excellent problem-solving and analytical skills, and ability to work independently and as part of a team.
Preferred Qualifications:
Experience with specific analytical instruments, such as HPLC, GC, and UV-Vis, and certification in validation or quality assurance.
Benefits:
As a Senior Validation Operations Specialist, you will have the opportunity to work with a global leader in engineering and sciences services, serving visionary companies with specialized experts in engineering and science initiatives.
You will be part of a team that is dedicated to delivering high-quality results and ensuring regulatory compliance, and will have access to training and professional development opportunities to enhance your skills and knowledge.
Location:
The salary for this role is estimated to be around $120,000 - $160,000 per year, depending on location and experience.
About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions, helping companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.
We have a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe.
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