Sr. Process Engineer

Celltrion Branchburg; Branchburg Township (NJ); Hybrid; USD 87,000 - 150,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision insurance

Life insurance

Company-matched retirement plan

Wellness programs

Disability benefits

Hybrid work flexibility

Job summary

Celltrion Branchburg, LLC seeks an experienced manufacturing process engineer to support clinical and commercial operations. You will work with Process Team across TS/MS, manufacturing, validation, and QA to optimize equipment and bioprocess systems.

Responsibilities include controlling equipment performance, leading investigations, maintaining SOPs, and supporting CAPAs, change controls, and safety assessments, while ensuring cGMP compliance. Hybrid work options available.

Qualifications

• 3+ years of experience in a cGMP environment or equivalent education.
• Knowledge of biopharmaceutical processes and equipment (bioreactors, centrifuges, TFF, chromatography).
• Strong written and oral communication skills.
• Self-directed, proactive, and capable of working independently.

Responsibilities

• Plan, coordinate, and execute projects supporting clinical and commercial manufacturing.
• Lead equipment-related investigations and support CAPAs and changes.
• Ensure regulatory compliance from equipment and process performance perspective.
• Own SOPs and participate in Manufacturing Batch Records reviews.

Skills

Communication skills

Independent work

Problem solving

cGMP knowledge

Education

Bachelor of Science, Chemical or Mechanical Engineering

Job description

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products.

Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.

Position Brand Description:

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 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 planning, coordinating, and executing projects supporting clinical and commercial manufacturing operations.
• 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 and sharing process knowledge. 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 investigations. 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

Basic Requirements:

• 3+ 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.

Education Requirements:

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

This role is exempt and the anticipated compensation for this role is $87,000 - $150,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

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.

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.