Manager, QA Validation - Aseptic Processing
Regeneron Pharmaceuticals Inc

Job Info

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The QA Validation department at Regeneron is adding to their team! The Manager for QA Validation within our Fill Finish area would lead the department that is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Rensselaer facility. This group also participates and defends validation data in FDA and other regulatory inspections.

The day to day of a Manager for QA Validation could include, but are not limited to, the following:

• Leads cross-functional teams in developing Validation standards and guidelines which includes exploring new techniques, methods and other industry practices; collaborates with functional departments to resolve issues.
• Leads projects by developing appropriate plans, schedules, resource loading and other project objectives; execution of validation projects and coordinating Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols and writing reports of validation results.
• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports
• Prepares equipment for qualification studies and completes qualification and validation studies according to approved protocols and SOPs
• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements; developing validation work plans, establishing objectives, and assigning tasks; counsels employees about work performance; conducts hiring and discharge interviews
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality; participates in regulatory and customer activities.
• Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.
• Plays a proactive role in developing and applying new approaches and processes to validation strategies. Designs and develops policies related to validation and ensures that they are effectively administered and align with regulatory requirements.
• Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions including failure investigations, change controls and associated test plan documentation, SOPs, validation protocols and summary reports & Validation Master Plans

To be considered for this role, you must possess:

• Associate Manager: BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 6+ years of related experience within the field
• Manger: BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes
• Experience leading, supervising, or managing others required
• May substitute proven experience for education requirement

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.

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