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ProBio · 2 weeks ago

Automation Engineer, GMP

Pennington, NJ

Full-time

Onsite

Senior Level

$90K/yr - $120K/yr

5+ years exp

GenScript Biotech Corporation is a global biotechnology group committed to enhancing health through biotechnology. The Automation Engineer is responsible for managing the site’s automation systems, ensuring compliance with regulatory standards, and collaborating with various departments to enhance automated processes.

BiopharmaBiotechnologyLife ScienceMedicalPharmaceutical

H1B Sponsor Likely

Responsibilities

Work closely with stakeholders to understand and fulfill system requirements and improve the quality of automated processes

Collaborate with stakeholders, including Area Managers, System Owners, and System Users to ensure successful onboarding, use and retirement of automation systems

Develop appropriate Validation Protocols, Reports, and Lifecycle documents

Execute Validation Protocols and collecting test evidence

Create and improve Administration SOPs of automation systems

Monitor integrity, availability, performance and operability of automation systems

Identify, investigate and correct technical issues, including performing root cause analysis for production errors

Make adjustments, enhancements and applying patches or upgrades as required for automation systems, while adhering to the Change Control process

Understand network operations, system operations, and Cloud-based systems

Administer user access management

Ensure compliance with applicable regulatory standards

Maintain up-to-date knowledge of current technology trends, programming languages, and automation best practices for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and QC instruments

Author appropriate Change Controls and Test Scripts and serve as the Subject Matter Expert for applicable technical changes in automation systems

Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT)

Liaison with Business, Quality Assurance, Managed Services, and IT to coordinate the Change Request processes

Qualification

IT NetworkingIndustrial Automation SystemsSCADA SystemsComputer System ValidationBiologics Process EquipmentMicrosoft OfficeSAPMaximoVeeva VaultProblem-Solving SkillsCollaborationCommunicationAdaptabilityProject Management

Required

Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus

Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7 years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems

Proven experience as an IT Automation Engineer or similar role

Direct knowledge of the biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure

Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, SCADA system architecture, Biotech Process Equipment/Systems

Proficient in use of electronic systems, such as Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS)

Knowledge of domestic / international regulatory guidelines / compendia and industry standards (FDA, ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems, including but not limited to 21 CFR Part 11, EU Eudralex Annex 11 and GAMP 5

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

Comfort with collaboration, open communication, reaching across functional borders and being proactive

A strong focus on business outcomes

Ability to prioritize and juggle multiple concurrent projects and day-to-day requests

Company

ProBio

ProBio is a global contract development and manufacturing (CDMO) organization, which aims to accelerate the manufacturing of life-changing drugs, discover novel therapeutic targets, and develop innovative therapeutic approaches to manufacture best-in-class DNA, RNA, and protein-based therapeutics.

Founded in 2002

Pennington, New Jersey, USA

201-500 employees

https://probiocdmo.com/

H1B Sponsorship

ProBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (5)

2024 (8)