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About the Role
Lead a technical team responsible for automation systems support across manufacturing and support areas. Manage team performance, coordinate deviation investigations, deliver large-scale improvement projects, and ensure automation systems remain compliant and reliable. Collaborate with Manufacturing, Quality Assurance, Engineering, and IT infrastructure teams.
Responsibilities
- Lead and develop a technical automation team, managing performance, development, and results while empowering team members to deliver under demanding timelines and situations.
- Provide technical automation systems support to manufacturing and support areas.
- Coordinate investigations of manufacturing deviations and anomalies related to automation systems, IT infrastructure, and software.
- Lead projects related to corrective action and systems performance improvement.
- Deliver on large-scope projects requiring analysis of business metrics including production, performance, and operational data.
- Provide technical review of lifecycle documentation, software testing, and protocols.
- Lead the team in supporting Quality Assurance with automated system test plan approval for change control and validation projects.
- Create, maintain, and approve SOPs and Software Lifecycle Documentation.
- Develop and edit design documents, technical evaluations, and test plans in accordance with cGMP and GAMP 5 guidelines.
- Manage and maintain project portfolio and work metrics, departmental data, and technical reports.
- Communicate effectively across engineering staff, cross-functional departments, and management.
- Design, configure, and troubleshoot networked systems.
- Balance changing priorities and increasing workload through timely decision-making and effective delegation.
Requirements
- BS in Engineering, Computer Science, or a related field.
- Manager: 7+ years of experience in the design, configuration, administration, and management of software, databases, and computerized systems.
- Senior Manager: 8+ years of relevant experience; level determined based on qualifications.
- Prior experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred.
- Solid understanding of PI Historian and Rockwell applications.
- Familiarity with PLC, HMI, historian, and product testing software strongly preferred.
- Highly skilled in developing and editing Software Lifecycle Documentation, design documents, technical evaluations, and test plans following cGMP and GAMP 5 guidelines also preferred.
Skills
- Automation systems support
- Deviation investigation
- Project management
- cGMP
- GAMP 5
- PI Historian
- Rockwell applications
- PLC
- HMI
- Historian software
- Product testing software
- Software Lifecycle Documentation
- Design documents
- Technical evaluations
- Test plans
- Networked systems design
- Configuration
- Troubleshooting
Location
- Menands, New York, United States
Work Type
- On-site
- Monday - Friday 8am - 4:30pm
Experience Level
- Manager
- Senior Manager
Education Level
- BS in Engineering, Computer Science, or a related field
Salary/Compensations
- $121,100.00 - $231,000.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.