Summary: The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
Lead process improvement projects to improve the validation of computerized systems
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Participates in regulatory audits and communicates company’s computer validation policies.
Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
Trains /advises less experienced Specialists and Technicians.
Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
Technical writing experience.
Generation of Validation documents.
Review and Approval of Validation documents.
Strong attention to detail and accuracy.
Experience in risk assessments in relation to validation activities.
Advise and support all teams on computer validation activities.
Education and Experience:
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education. Experience with process control systems necessary.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.