Project Manager, QA Validation

Rensselaer, NY, United States
Jan 16, 2021
Required Education
Masters Degree/MBA
Position Type
Full time
We are currently looking to fill a Project Manager, QA Validation position. This position will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In this role, a typical day might include the following:
• Supervising compliance of area operations, including trending of failures and evaluating efficiency of corrective actions
• Generating validation project deliverables and schedule, including integration of deliverables/schedule into larger project team plan
• Evaluating achievement versus schedule plan, and translates information to reportable metrics
• Formulating efficiency improvement to ensure timeliness of validation deliverables
• Deliver project reports to management
• Generating, executing and reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Preparing equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change control and SOPs
• Collaborating with functional departments to resolve issues
• Coordinating with other departments or outside contractors/vendors to complete validation tasks
• May train/advise less experienced personnel, may directly supervise contingent workers

This role might be for you if you:
• Have validation experience in the pharmaceutical industry
• Can coordinate with other departments or outside contractors/vendors to complete validation tasks
• You continuously seek to improve processes for improved performance

To be considered for this role you must hold a Bachelor's degree in Engineering, Chemistry, or Life Sciences with 8+ years of related experience for Associate Project Manager level, 10+ years for Project Manager level, 12+ years for Senior Project Manager level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.