Principal Automation Engineers - Rensselaer, NY | Biospace
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Principal Automation Engineers

Regeneron Pharmaceuticals, Inc.

Rensselaer, NY
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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: Performs advanced technical planning, system integration, maintenance, verification, and validation of PLC and HMI based automated process control systems and process monitoring systems in a biopharmaceutical manufacturing cGMP environment for Regeneron's Industrial Operation and Product Supply organization. The Principal Engineer is the site Subject Matter Expert on automated process control and monitoring systems for their area of responsibility and is recognized as a technical expert by peers and other personnel within the business unit.

Essential Duties and Responsibilities include, but are not limited to the following:
* Independently manages or provides leadership to all phases of automation engineering projects and oversees these projects from conception, design and initial specifications through completion and turnover. This includes developing detailed and accurate project schedules while collaborating with internal cross functional teams, end users, and third party contacts to design, develop, document and maintain software architecture deliverables for various projects for both embedded and application software.
* Applies state of the art techniques to develop automation solutions or improve automation processes.
* Provide solutions complex problems through modification of standard technical principles that reflect understanding of business objectives and quality implications.
* Provide detailed technical automation support and troubleshooting to Manufacturing, Quality, and Facilities according to established SOPs and departmental practices.
* Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software.
* Provide guidance and develop 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 advanced technical support to manufacturing activities with process control and process monitoring equipment software design, commissioning, protocol review, and testing to meet end user requirements.
* Author or provide guidance in the development of 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 manufacturing process control projects related to corrective action, equipment performance improvement, and new equipment.
* Develop test plans and implement software/hardware improvements to automated process control and process monitoring equipment according to change control procedures.
* Provide engineering guidance to other departments, helps train new and current engineers, and keeps abreast of industry trends and issues.
* Conduct engineering studies and investigations, and prepare reports for engineering leadership.
* Draft and develop standard operating procedures and automation engineering documents.
* Communicate effectively with engineering staff and cross functional departments.
* Complete assigned work with little to no management oversight.
* Complete all associated training and maintain required qualifications and/or certifications.
* May supervise a small group of senior engineers, junior engineers and 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.
* Develop, propose and abide by stand operating procedures and automation engineering documents.
* May provide training or presentations on basic automation systems and tasks to department personnel.

Knowledge and Skills:
* Must have advanced experience or training and demonstrate a high level of proficiency with programming and troubleshooting PLCs, HMIs, and computerized system design, installation, and support in a cGMP industrial setting.
* Demonstrated excellence in programming and troubleshooting PLCs/HMIs for complex processes which involve the use of batch programming (S-88), data acquisition, and PID control.
* Advanced knowledge of electrical systems, instrumentation and process controls.
* Advanced knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility.
* Advanced experience in developing and creating 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.
* Advanced understanding of bioprocessing equipment design principles and sanitary equipment design requirements.
* Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. (e.g. validation, process engineering, quality, etc.).
* Detailed understanding of bioprocessing equipment design of cGMP software quality system principles, and sanitary equipment design requirements, and data integrity regulations.
* Excellent written and verbal communication skills.
* Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management without assistance.
* Ability to communicate effectively with engineering staff, cross functional departments, and management.
* 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.
* Ability to manage a small group of direct reports and contractors within department.
* Ability to mentor and develop senior and junior engineering staff and lead teams in technical task completion.


Education and Experience:
* Requires a BS/MS in engineering or related field and at least 8 years of experience in leading, designing, programming, and maintenance of process control systems and data acquisition systems.
* Prior experience within a pharmaceutical or biopharmaceutical manufacturing facility is required.
* Specific knowledge of Allen-Bradley and Siemens PLC control systems (RSLogix 500/5000 and S7/TIA Portal).
* Specific knowledge of Human Machine Interface systems (HMI/GUI) and video graphic chart recorders is required.
* Specific knowledge of industrial communication networks (e.g. AB DeviceNet, Ethernet IP, Profinet, field bus networks, RS-232).

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.