Senior Automation Systems Administrator, Manufacturing & Lab Support

Initial Therapeutics, Inc.; Village of Menands (NY); On-site; USD 78,700 - 128,700; Full time

Job summary

Regeneron is seeking a Senior Automation Systems Administrator in Menands, NY, to join the IOPS team. You will configure and maintain cGMP software for process control, monitoring, and testing, ensuring compliance and leading validation activities.

You will manage change controls, lead multiple projects, and provide advanced automation support across Manufacturing, QC, and Facilities, with LIMS/Historian integration and SOP development.

Qualifications

• BS/BA in Science, Engineering, or related field with 5+ years of relevant experience
• Experience in cGMP environments and cleanrooms
• Experience leading SAT/FAT, validation, and qualification efforts

Responsibilities

• Configure and maintain cGMP software for process control, monitoring, and testing.
• Define backup/archive requirements and recovery processes to meet RTO/RPO.
• Handle change controls, risk assessments, and quality reviews to ensure compliance.
• Lead SAT/FAT, validation, and qualification activities; develop and execute testing protocols.
• Lead change controls and CAPA investigations.
• Lead software and equipment implementation projects.
• Provide advanced automation support to Manufacturing, QC, and Facilities.
• Integrate with LIMS/Historian; develop system SOPs and push continuous improvements.
• Pharma/biopharma manufacturing experience preferred.
• Experience configuring/troubleshooting process control and product release testing systems.
• Experience creating software lifecycle docs and test plans per GAMP5.
• Knowledge of cGMP biotech/pharma operations and regulatory policies.

Skills

cGMP systems

Regulatory compliance

Change control

System validation

Project leadership

Technical troubleshooting

Manufacturing software

Education

BS/BA in Science, Engineering, or related field

Tools

LIMS

Historian

SCADA

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Senior Automation Systems Administrator to join our IOPS team, providing expertise in the configuration and administration of automated and computerized system software and firmware across our manufacturing and laboratory operations. In this role, you will ensure systems remain in a compliant and validated state, lead projects, drive continuous improvement, and deliver advanced technical support while collaborating with Manufacturing, Quality Control, Facilities, and cross‑functional teams. This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Menands, New York, United States
• Work model: Monday - Friday 8am - 4:30pm

Discover your role:

• Configure and maintain cGMP software for process control, monitoring, and testing; manage user access, system security, configuration management, and recipe and method management to meet regulatory requirements
• Determine data backup and archive requirements and configurations to meet defined RTO and RPO targets; design and maintain recovery processes
• Ensure systems remain in a compliant state by processing change control requests including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Support and lead system SAT/FAT, validation, and qualification efforts; generate and execute testing and qualification protocols for automated process, monitoring, and testing equipment
• Initiate, author, and review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and corrective and preventive action plans; lead investigations and root cause analyses for non‑compliance issues
• Lead multiple small to medium‑sized projects related to corrective action, software performance improvement, and new equipment and software implementation
• Provide advanced technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities in accordance with established SOPs and departmental practices
• Support system integration with existing platforms such as LIMS and Historian; draft, approve, and follow relevant system software SOPs and policies; identify opportunities for continuous improvement in processes, procedures, and architecture standards
• Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred
• Advanced experience configuring and troubleshooting process control, monitoring, and product release testing systems including design and installation
• Expertise in developing Software Lifecycle Documentation, software design documents, technical evaluations, and test plans for cGMP process equipment following GAMP 5 guidelines
• Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods

This role requires:

• BS/BA in Science, Engineering, or a related field with 5+ years of relevant experience (may consider equivalent combination of education and experience)
• Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make‑up and nail adornments when wearing cleanroom attire
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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.

Salary Range (annually)

$78,700.00 - $128,700.00