Associate Director, Site Automation OT Equipment

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 148,000 - 241,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Site Automation to lead automation across manufacturing, testing laboratories, and facilities operations at the Menands, NY site.

You will supervise a team, drive cGMP automation quality systems, software change control, and equipment qualification while collaborating with Manufacturing, Quality, Engineering, and vendors. This on-site role requires a BS/BA in Science/Engineering or Software Programming and 10+ years in automated

Qualifications

• BS/BA in Science, Engineering, or Software Programming or equivalent direct experience with automated control systems.
• MBA, MS or advanced degree preferred.
• 10+ years of experience with automated equipment in pharma/biopharma or related regulated industry.

Responsibilities

• Lead the automation team by setting expectations and ensuring compliance with policies and procedures.
• Oversee cGMP software administration and automated system evaluation programs.
• Oversee investigations related to deviations, anomalies, and automation issues.
• Lead projects for corrective action and equipment performance improvement; manage work orders and quality items.
• Maintain budget forecasts and headcount planning; support vendor relationships and approved suppliers.

Skills

cGMP knowledge

Software change control

Automation leadership

Vendor management

Regulatory compliance

Education

BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems

MBA, MS or advanced degree preferred

Job description

Build our future together:

A t Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Site Automation to join our Operation Technology Small Equipment, supporting either Red Mill (Bulk Manufacturing) or Temple Lane (Internal Fill Finish) Site. This role is providing technical and automation leadership across manufacturing, testing laboratories, and facilities operations. In this role, you will supervise a team and drive accountability across cGMP automation quality systems, software change control, corrective actions, and equipment procurement and qualification — while collaborating with Manufacturing, Quality Control, Engineering, and vendor partners.

When & where:

• Location: Menands, New York
• Work model/flexibility: Monday - Friday 8am - 4:30pm, onsite
• Travel percentage: 5-10% to US & International travel

Discover your role:

• Lead the automation team by setting clear expectations and modeling compliance; ensure adherence to all departmental policies and procedures
• Oversee the cGMP software administration program and automated system periodic evaluation program; ensure SOPs and Software Lifecycle Documentation remain aligned with current regulatory standards and guidelines
• Oversee investigation support for manufacturing deviations, lab testing anomalies, and issues related to automation, software, and hardware
• Lead projects related to corrective action and equipment performance improvement; ensure timely completion of all departmental projects, work orders, and quality management items
• Maintain budget forecast and compliance for the direct team; provide headcount forecasts for department growth to senior management
• Support vendor relationships and ensure compliance with approved suppliers; oversee equipment procurement, commissioning, and equipment and software qualification activities

This role requires:

• BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems or equipment in lieu of degree
• MBA, MS or advanced degree preferred
• 10+ years of experience with automated equipment in the pharmaceutical or biopharmaceutical industry or related regulated industry, including at least 5 year of direct experience in the design, installation, maintenance, and/or troubleshooting of automated control systems
• Demonstrated experience leading or managing automation teams in a cGMP regulated environment
• Strong working knowledge of cGMP quality systems, software change control processes, and regulatory standards applicable to automated systems
• Experience with vendor management and approved supplier compliance programs preferred

We are committed to building a workplace with an inclusive culture. 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.

Salary Range (annually)
$147,800.00 - $241,200.00

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.