Sr. Automation Systems Administrator

Location
Rensselaer, New York, US
Posted
May 11, 2018
Ref
13334BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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: Provide expertise in the configuration and administration of automated/computerized system software and firmware to meet cGMP and procedural requirements for Regeneron's Industrial Operation and Product Supply organization.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Configures and evaluates user access to control system security to meet regulatory requirements.
• Determine data backup / archive requirements and configurations to meet defined RTO and RPO. Design recovery process.
• Configuration management and recipe/method management.
• Creates and maintains configuration specifications for cGMP software for process control, monitoring and testing.
• Support system SAT/FAT, validation and qualification efforts.
• Review and approve system lifecycle design documentation.
• Ensure systems remain in compliant state - Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments.
• System integration with existing systems (ex. LIMS, Historian) as required by business needs.
• Draft, approve and follow relevant system software SOPs and policies.
• Identify areas for continuous improvement in business processes, administrative procedures and/or configurations/architecture standards.
• Generate and execute necessary testing and qualification protocols as related to the overall design and performance of automated process, monitoring, and testing equipment.
• Lead multiple small to medium sized projects related to corrective action, software performance improvement, and new equipment/software.
• Provide advanced level of technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices.
• Initiate, author, review documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Participate/lead/author investigations and root cause analysis for department issues of non-compliance.
• May supervise a small group of direct reports and/or contractors within department.

Knowledge and Skills:
• Advanced experience with configuration and troubleshooting of process control, monitoring, and product release testing systems including design and installation.
• Current knowledge of cGMP biotech/pharma operations, regulatory and quality policies, procedures and documentation methods.
• Expertise in developing and editing Software Lifecycle Documentation, software design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines.
• Must be able to work independently and have project management capabilities.
• Strong written and verbal communication skills with ability to delegate tasks.
• Knowledge of biotech/pharma manufacturing process/supporting laboratory testing and regulatory requirements, related terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation.
• Strong leadership capabilities and organizational skills.
• 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.
• Working knowledge of word processing, spreadsheet, PowerPoint and database management software.
Education and Experience:
• BS/BA in Science/Engineering or related field preferred along with 5 years of relevant experience in manufacturing/lab/IT setting. Equivalent experience in the configuration, administration and maintenance of process/testing control systems and/or data acquisition systems will be considered in lieu of the educational requirement. 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 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: 13334BR