Assoc. Manufacturing Engineer, Technical Support (3rd Shift)

Job Description

Legend Biotech is seeking an Associate Manufacturing Engineer to join their Technical Operations team in Raritan, NJ. This role will focus on providing technical support for a new CAR-T manufacturing process, acting as a subject matter expert and first point of contact for manufacturing issues. Responsibilities:

• Partnering with Quality, Compliance, and technical experts to resolve process issues.
• Supporting manufacturing investigations and CAPAs.
• Liaising with equipment suppliers for support.
• Analyzing key process indicators and identifying improvement opportunities.
• Conducting manufacturing observations to collect process health data.
• Serving as a primary point of contact across manufacturing and support organizations.

Requirements:

• Bachelor’s degree in engineering or related field (or equivalent experience).
• 2-3 years of operations experience in a cGMP environment within the biotech/biopharma industry.
• Experience in Cell/Gene Therapy cGMP manufacturing is preferred.
• Ability to support process, operational, and quality improvements.
• Proficiency in writing SOPs and Quality Risk Assessments.
• Ability to manage tasks and meet deadlines in a fast-paced environment.
• Willingness to work both 2nd and 3rd shift hours, with initial training on 2nd shift.

What This Role Offers:

• Opportunity to work with Quality, Compliance, and technical experts.
• Chance to support process, operational, and quality improvements.
• Exposure to Cell/Gene Therapy cGMP manufacturing.