Project Manager, Computer Systems Validation

The QA Validation department is adding to their team! We are hiring a Project Manager, Software Validation. 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.

As a Project Manager, Software Validation, a typical day might include 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.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates companies computer validation policies.
• Assesses companies computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports.
• May supervise, lead, or manage lower-level personnel.
• Trains /advises less experienced Specialists and Technicians.
• Manage software validation and departments projects as needed          
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality
• Ensure software validation activities adhere to the design controls and software validation procedures

This role may be for you if you are looking to:

• Participate in regulatory and customer activities.
• Collaborate with functional departments to resolve issues.
• Play a proactive role in developing and applying new approaches and processes to validation strategies.
• Presents/defends validation data to FDA and other regulatory agencies

To be considered for this role you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with

• Associate Project Manager: 8+ years of related experience within the fields of computers or biotechnology
• Project Manager: 10+ years of related experience within the fields of computers or biotechnology;
• Experience in a regulated manufacturing environment preferred.

#REGNQA #LI-Hybrid

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.

Salary Range (annually)

$85,800.00 - $157,400.00