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Rensselaer, New York - USD Full Time Posted: Friday, 8 November 2019
 
 
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: Provides expertise in the design, deployment, and maintenance of industrial computerized process control and process monitoring systems in a biopharmaceutical manufacturing cGMP environment for Regenerons 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:
Provide advanced level of technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices
Lead and perform investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
Lead engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, protocol review, and testing to meet end user requirements
Update or author system specifications, user requirements, functional requirements, and system design specifications
Generate and execute necessary testing and qualification protocols as related to the overall design and performance of automated process and monitoring equipment
Lead multiple small to medium sized manufacturing process control projects related to corrective action, equipment performance improvement, and new equipment
Design, develop, and implement software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
Develop and execute test plans for software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
Provide guidance to Automation Personnel according to established SOPs and departmental practices
May provide training or presentations on basic automation systems and tasks to department personnel
Follow standard operating procedures and automation engineering documents
Develop and draft standard operating procedures and automation engineering documents
Complete assigned work with some management or senior engineering staff oversight
Communicate effectively with engineering staff and cross functional departments
Complete all associated training and maintain required qualifications and/or certifications
May supervise a small group direct reports of junior engineers and/or contractors within department
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:
Advanced skills with programming and troubleshooting PLCs, HMIs, and computerized system design, installation, and support in a cGMP industrial setting
Expert in PLC/HMI logic programming and troubleshooting Allen-Bradley and Siemens products which involve the use of batch programming (S-88), data acquisition, and PID control
Demonstrated knowledge of electrical systems, instrumentation and controls
Strong knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility
Expertise in developing and editing Software Lifecycle Documentation, engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
Strong understanding of bioprocessing equipment design principles and sanitary equipment design requirements
Strong written and verbal communication skills with ability to delegate tasks
Proficiency with standard business software is required (Word, Excel, etc.)
Able to balance changing priorities with increasing workload by making timely decisions
Able to interact with employees at all levels and cross functionally across multiple departments
Ability to manage and develop direct reports through mentoring and leadership
Education and Experience:
BS in Engineering or related field and 5 years of experience in the design and maintenance of process control systems and/or data acquisition systems
Equivalent relevant experience in the design and maintenance of process control systems and/or data acquisition systems may be considered in lieu of a degree
Specific knowledge of Allen-Bradley and Siemens control system products and video graphic chart recorders is required
Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility 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 Regenerons 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.

Rensselaer, New York, United States of America
Engineering
USD
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
JS2365_746B7D5D82F850E5DF474CB51B61A455/784839750
11/8/2019 9:54:03 AM

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