Sr. QA Validation Specialist (Drug Product Validation Oversight)
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: Work with external partners, CMOs and internal teams to validate drug product process (e.g. filling, device assembly, and packaging).
Essential Duties and Responsibilities include, but are not limited to, the following:
• Generates, and/or reviews and approves master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Travels to external sites to support Regeneron related validation activities.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves validation deviations, investigations, and corrective actions.
• Reviews, edits and approves change controls, SOPs, reports and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Trains/advises and/or supervises less experienced Specialists.
• Manages projects and prepares status reports.
• Other duties assigned by management.
Knowledge Skills & Abilities:
• Ability to maintain integrity and honesty at all times.
• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Continuously drive to improve processes for improved performance.
• Demonstrate respectful behavior at all times.
• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint).
• Gathers and organizes information.
• Meets commitments on time.
• Follows directions; performs well-defined tasks.
• Effective time management skills.
• Seeks to identify continuous improvement needs.
Education and Experience:
• BS/BA in Engineering, Chemistry, or Life Sciences with minimum 5 year of GMP experience within the field preferred; may substitute relevant experience for education. Validation and/or drug product filling experience desired.
**Level will be determined based upon experience**
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.