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.
Manages an automation team to ensure work efforts are aligned in order to successfully execute tactical plans that enable business operations within assigned area of responsibility. Ensures successful results of designated initiatives and tasks are achieved. Ensures accurate accounting of and appropriate deployment of resources. This role also provides technical and automation support to Industrial Operation and Product Supply. The position is also responsible for the oversight of cGMP automation quality systems, software change control, and automation related corrective actions within Regeneron's Industrial Operation and Product Supply organization.
Level to be determined based on qualifications relevant to the role
Essential Duties and Responsibilities include, but are not limited to the following:
Manages and provides leadership to a group of Automation employees and contractors that support Regeneron's Industrial Operation and Product Supply organization.
Supervises and provides leadership to define scope, schedule and cost towards completion of capital projects.
Identifies and actively pursues opportunities for efficiencies in Automation department work processes.
Oversees the maintenance of cGMP Software administration program.
Provides leadership and guidance to successfully implements modification/change control procedures and protocols.
Supports Validation with initial design review of automation documentation, software testing, and performs protocol reviews.
Provides leadership and develops automation plans to resolve automation issues or improve automation processes.
Provides leadership and develop new approaches to resolve issues through adaptations and modifications of standard technical principles that reflect understanding of business objectives and quality implications.
Provide leadership and automation support and troubleshooting to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices.
Provide leadership to teams conducting engineering studies and investigations, and prepare reports for department and company leadership.
May gather production, performance and other operational data to determine what changes in processes or procedures are needed to improve to meet objectives. May compile such data and present to Directors and Sr. Leadership, where appropriate.
Resolves technical or staffing issues as they arise, within the scope of their authority.
Communicates effectively with engineering staff and cross functional departments.
Completes all associated training and maintain required qualifications and/or certifications for self and direct reports.
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
Knowledge and Skills:
Knowledge of Historians and MES systems and networks strongly preferred.
Knowledge of Allen-Bradley and Siemens PLC control systems (RSLogix 500/5000 and S7/TIA Portal).
Knowledge of Human Machine Interface systems (HMI/GUI) and video graphic chart recorders is required.
Knowledge of industrial communication networks (e.g. AB DeviceNet, Ethernet IP, Profinet, field bus networks, RS-232).
Ability to mentor and motivate a team of automation personnel and contractors to deliver results under demanding timelines and situations.
Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management independently.
Ability to communicate with engineering staff and customers at all levels and capable of managing their expectations.
Ability to convince management on courses of action using both written and verbal methods.
Able to balance changing priorities with increasing workload by making timely decisions and delegating tasks
Able to interact with employees at all levels and cross functionally across multiple departments.
A basic understanding of bioprocessing and testing equipment design, cGMP software quality system principles, and sanitary equipment design requirements, and data integrity regulations.
Familiarity with ISA S88/S95 standards
Expertise in developing and editing Software Lifecycle Documentation, engineering design documents, technical evaluations, and test plan documentation while applying the requirements for cGMP process equipment and following GAMP 5 guidelines.
Excellent written and verbal communication skills
Education and Experience:
Manager Automation: Requires a BS/MS in engineering or related field and 7+ years of experience in leading, designing, programming, and maintenance of control systems and data acquisition systems.
Senior Manager Automation: Requires a BS/MS in engineering or related field and 8+ years of experience in leading, designing, programming, and maintenance of control systems and data acquisition systems.
Requires demonstrated experience in project management and leading small teams.
Prior experience within a pharmaceutical or biopharmaceutical manufacturing facility is required.
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.
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