Project Manager, Computer Systems Validation
Company: Regeneron Pharmaceuticals, Inc.
Posted on: January 25, 2023
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
- 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
- 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
- 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
- Manage software validation and departments projects as
- Reviews internal and external requirements and implements
required processes, as needed, to meet expectations regarding
- Ensure software validation activities adhere to the design
controls and software validation proceduresThis 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
agenciesTo 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.
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
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Project Manager, Computer Systems Validation, Executive , Troy, New York
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