Associate Manager, Equipment Engineering
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: Responsible for overseeing a team of Equipment Engineers in the Rensselaer Technical Operations Engineering department. The Equipment Engineering team is responsible for: specifying and commissioning small equipment and equipment components, evaluating the functional equivalence of process and utility equipment and components, authoring of test plans to demonstrate suitability of replacement equipment, authoring of like for like replacement test plans, developing and maintaining applicable Standard Operating Procedures, and developing Standard Equipment Specifications for process and utility equipment.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for ensuring training, development, and compliance of direct reports.
• Sets priorities for the Equipment Engineering team.
• Tracks progress on team deliverables, including but not limited to: resolution of change notifications, equipment obsolescence projects, CAPAs, change controls, standard equipment specification, like for like test plans, and adherence to due dates.
• Provides tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions) and other compliance metrics for the Engineering department.
• Interface regularly with FMM Inventory, QA Validation, Manufacturing, Facilities, and other functional areas in order to facilitate decisions and work related to team deliverables.
• Specifies cGMP process equipment, components, and spare parts.
• Acts as a Technical Lead for the equipment spare parts scope of large capital projects.
• Evaluates new equipment and components for Functional Equivalence to existing equipment and components.
• Authors, reviews, and revises Standard Equipment Specifications.
• Assists or leads investigations relating to potential equipment problems.
• Assists or acts as a Subject Matter Expert during regulatory inspections.
• Assists in development of department policies, procedures and specifications.
• Assists in the design review of equipment, and approved supplier lists for equipment components and spare parts.
• Writes and executes test plans to demonstrate equipment suitability or functional equivalence.
• Implements corrective/preventative actions for existing equipment.
• Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
• Maintains company reputation by enforcing compliance with local, state, and federal regulations.
Education and experience:
• Requires BS/BA or higher in engineering with 6+ years of experience in engineering. Direct experience with biopharmaceutical process equipment and 2-3 years of experience in a leadership role is preferred.
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.
Requisition Number: 13469BR