Engineer II, Automation Validation

Job overview

Engineer II, Automation Validation is a site-based role in Pennington, NJ, supporting the facility and requiring gowning in manufacturing suites. Compensation is not specified. The role supports BeOne Medicines’ Automation Validation and Computerized System Validation function and its regulatory compliance objectives. The engineer validates automated manufacturing and computerized systems, develops and reviews controlled documentation, and supports projects from design and commissioning through qualification and production implementation. This work helps ensure systems meet operational, quality, safety, and regulatory requirements.

What you'll do

• Develop and approve cGMP documents, including qualification documents, validation plans, SOPs, reports, periodic reviews, and requalification
• lead validation of automated manufacturing, equipment, control, and computerized systems
• develop and maintain automated test scripts and frameworks where appropriate
• validate PLC, HMI, SCADA, DCS, EMS, vision, and data acquisition systems
• assess GxP, data integrity, and electronic records compliance
• participate in design reviews, FAT, SAT, commissioning, qualification, and production implementation
• conduct risk-based assessments
• monitor validation KPIs, schedules, budgets, and resources
• manage validation projects and consultants as needed
• review equipment specification, design, procurement, installation, and validation
• plan projects and prepare documentation
• investigate validation discrepancies and deviations
• work with manufacturing, quality, and engineering associates.

What we're looking for

Skills & competencies

engineer ii

automation validation

computerized system validation

cgmp

manufacturing systems

plc

hmi

scada

dcs

data integrity

pennington nj

beone medicines

travel up to 5%

Work arrangement

• Weekend coverage required

Why this role

Site-based work includes gowning in manufacturing suites. The source states travel may be up to 5%, including visits to partner or manufacturing sites.

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.