Automation Engineer, GMP

About Gen Script

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002. It has a presence across North America, Europe, Greater China, and Asia Pacific, and operates a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

Pro Bio, a subsidiary of GenScript, is a biopharmaceutical R&D and production platform focused on cell and gene therapy, vaccines, and biopharmaceutical discovery. It provides end‑to‑end CDMO services from target development to commercial production.

The Automation Engineer is responsible for administration and management of the site’s automation systems, including SCADA, PLCs, notification systems, and computerized QC lab instruments. Responsibilities include installation, maintenance, backup, change control, validation, and retirement of systems.

The role works cross‑functionally with IT, Manufacturing, Facilities & Engineering, QC, QA, and external vendors to maintain systems and ensure adherence to regulatory requirements and SOPs.

• Work closely with stakeholders to understand system requirements and improve automated processes.
• Collaborate with stakeholders, including Area Managers, System Owners and users, to ensure successful onboarding, use and retirement of automation systems.
• Develop validation protocols, reports and lifecycle documents.
• Execute validation protocols and collect test evidence.
• Create and improve administrative SOPs for automation systems.
• Monitor integrity, availability, performance and operability of automation systems.
• Identify, investigate and correct technical issues with root‑cause analysis.
• Make adjustments, enhancements, and apply patches or upgrades as required through the change control process.
• Understand network, system and cloud‑based operations.
• Administer user access management.
• Ensure compliance with regulatory standards.
• Stay current with technology trends, programming languages and automation best practices for bioprocess equipment.
• Author change controls and test scripts; serve as SME for technical changes.
• Recommend and integrate new bioprocess equipment and PAT.
• Coordinate change request processes with business, QA, managed services, and IT.
• Training: cGxP; applicable corporate and departmental directives, policies and procedures; GMP and GTP; automation control and data acquisition; EHS; lab/biological safety; gowning.

• Expertise in IT networking and industrial automation systems, e.g., Rockwell Automation, Wonderware, Top View, Vaisala, Delta
  
  V, Repligen, Thermo Scientific instruments (plus).
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering or related field with 5–7 years of experience providing scientific knowledge of automation systems in biologics production.
• Proven experience as an IT Automation Engineer or similar.
• Direct knowledge of biologics process equipment, SCADA/control systems and supporting IT networking.
• Expertise in equipment qualification, computer system validation, SCADA architecture, biotech process equipment.
• Proficiency in electronic systems including Microsoft Office, Veeva Vault, SAP, Maximo, BAS.
• Knowledge of FDA, ICH, USP, EMEA guidelines and standards for validation of computerized equipment and systems including 21 CFR 11, EU Eudralex Annex 11, GAMP 5.
• Analytical thinker with strong problem‑solving skills and ability to adapt to changing priorities and deadlines.
• Comfortable with collaboration, open communication, cross‑functional teamwork and proactive engagement.
• Strong focus on business outcomes.
• Ability to prioritize and juggle multiple concurrent projects and daily requests.

Location:

Pennington, New Jersey – fully onsite.

Estimated salary: $90,000 – $120,000 annually.

GenScript USA Inc/Pro Bio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. The company's policy ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./Pro Bio Inc. maintains a drug‑free workplace.

Genscript USA Inc./Pro Bio Inc. will only contact candidates through verified application sources. The company does not request personal information from candidates through individual email or any other platform.