Process Engineer

This position is responsible for providing engineering support of manufacturing equipment and operations. This position will interact various team members on Process Team, including TS/MS, manufacturing, validation, and quality assurance, and other Celltrion Branchburg, LLC Sites as required. Knowledge of cell culture, purification and support systems, and its associated bioprocessing equipment used in the manufacturing of biotech products is required.

Manage for Results /Strategic Planning:

• Responsible for supporting clinical and commercial manufacturing operations through representation on Process Teams:
• Respond to and trouble shoot process equipment related issues; provide direct, on-the-floor engineering support of manufacturing processes. Use historian data and other sources of process data to extract and chart relevant process parameters on a continuous basis. Uses process knowledge to analyze possible solutions to solve a range of problems.
• Ensure regulatory compliance from an equipment and process performance aspect. Understand capability and capacity of unit operations and process. Active participation in Process Teams to verify that process is in control; use of first principles, RCA or other tools to reach conclusion and recommendations for remediation of any problems or deviations.
• Supports Process Team by responding to questions, sharing process knowledge, and troubleshooting issues as they occur. Respond to operations needs and handles standard and non-standard requests.
• Lead equipment related investigation and resolutions. Provide process related input to process team for deviations and observations. Make decisions that impact own priorities and allocation of time to meet deadlines.
• Execute, or assist, in process related change controls. Own equipment Standard Operating Procedures (SOP), related CAPAs and changes. Perform safety assessments as required for change controls and any project related activity. Effect incremental improvement.
• Perform key responsibilities of discipline other than Process Engineering;
  Automation – support measurement and control systems, Maintenance – ensuring an asset’s functionality is maintained.
• Creates or modifies SOPs for Engineering procedures as required. Own manufacturing SOP’s and participates in the reviews and approvals of operational SOPs and Manufacturing Batch Records, ensuring procedures can be executed as written to ensure practice matches procedure, as it relates to the process equipment and order of operations.
• Provide engineering support to Senior engineers for new product introduction, capital projects, and shutdown related activity.
• Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically.

• 0-5 years industrial experience in a cGMP environment, or experience through education.
• Knowledge of / experience with several biopharmaceutical processes and equipment, such as bioreactors, centrifuges, TFF and chromatography systems, media/buffer prep and CIP/SIP.
• Strong written and oral communication skills.
• Aggressive, curious, and solution driven. Self-directed personality, with ability to work independently, self-sufficiently, and proactively in the performance of work duties.

• Bachelor of Science, Chemical, Mechanical Engineering, related engineering discipline.

• Lifting up to 50 lbs. required.
• Required to be on call.
• Shift work may apply.

The anticipated compensation range for this role is $72,000 - $145,000

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided. This role requires minimal travel (less than 5%), the ability to lift up to 50 lbs.,

on-call availability, and may involve shift work.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.