Associate Manager, Instrument 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 Instrument Engineers in the Rensselaer Technical Operations Engineering department. The Instrument Engineering team is responsible for: assuring instruments are fit-for-purpose, helping end-users to discern the requirements of the application, supporting investigations where measurement issues may be a contributing root cause, developing and maintaining applicable Standard Operating Procedures, and developing specifications and standards for instruments.
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 Instrument Engineering team.
• Tracks progress on team deliverables, including but not limited to: instrument workflows in the Computerized Maintenance Management System, CAPAs, change controls, standard instrument specification, instrument data sheet templates, 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 Calibration, Automation, Manufacturing, Facilities, and other functional areas in order to facilitate decisions and work related to team deliverables.
• Specifies cGMP process instrumentation, components, and spare parts.
• Acts as a Technical Lead for instrumentation scope of large capital projects.
• Sets priorities for and completes Calibration Range and Tolerance Justifications forms for new instruments.
• Evaluates new instruments for Functional Equivalence to existing instrumentation that has become obsolete.
• Review and approve Input/Output lists for automated systems.
• Assists or may lead investigations relating to potential measurement problems.
• Conducts troubleshooting and root cause analysis for complex instrumentation and associated systems.
• Creates and maintains configuration specifications for cGMP manufacturing equipment.
• Assists in the design review of equipment, and approved supplier lists for instrumentation.
• Assists or may act as a Subject Matter Expert during regulatory inspections.
• Assists in the development of department policies, procedures and specifications.
• Writes and executes test plans to demonstrate instrument suitability.
• Implements corrective/preventative actions for existing equipment.
• Prepares engineering evaluations and test plans for change control documentation.
• 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: 13468BR