Manager-Plant Engineering

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 managing Frontline Plant Engineers (4-6) to support the commercial biomanufacturing utilities systems or operations and drive development/execution of productivity projects. The Leader will serve as a subject matter expert in one or more disciplines, can oversee, coordinate, review, and approve the work of Frontline Engineers, as well as acting in a mentoring role to ensure retention of technical depth and capability at Branchburg.

This position will be part of a Process Team and work with cross-functional team members to provide oversight and troubleshooting issues for reliable operation of their responsible system. They will provide technical support on day-to-day activities, analyze data and create reports, driving appropriate change controls/deviations.

She/He is expected to partner with leaders from Operations, Technical Operations, Laboratory, Engineering, Quality, Maintenance & Utilities to ensure efficient and effective communication to enable delivery on manufacturing objectives and continuous improvement, in compliance with Celltrion procedures, safety, cGMP and other regulatory requirements.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Manage team of plant engineers providing Front Line engineering support in the following areas:

a. Plant Engineering: Clean Utilities, Grey Utilities, HVAC, Chambers, Electrical.

2. Provide coaching/assistance to Front Line Engineers, but also help drive continuous improvements, support capital delivery, among other key strategic initiatives.

3. Provide Functional Leadership to Process Team engineering representatives by coaching the following business processes: change management, deviations/investigations, equipment and process improvements, process controls and variability reduction.

4. Makes decisions guided by engineering standards and policies, procedures and business plan that impact the ability of the Plant Engineers to meet performance objectives.

5. Support and peer review root cause analysis around equipment and operational events, support complex change controls, investigations. Lead Complex investigations and have strong root cause analysis capability.

6. Ensure continuous improvement mindset for process and operational improvements.

7. Apply statistical thinking and methods to understand process variability and capability and drive improvements.

8. Support regulatory inspections.

9. Provide oversight to process/plant equipment to ensure clear understanding of equipment flow, process flow and critical process requirements across all process steps on site.

10. Establish control systems to monitor, trend and verify equipment performance and downtime. Identify and optimize unit operation cycle time, loading, yield performance, etc.

11. Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized.

12. Develop, review and approve technical documentations such as SOPs, batch records, investigations, etc.

13. Present and attend various governance teams to represent process/plant engineering.

14. Support commissioning and qualification activities.

Manage Relationships with Key Stakeholders and Customers:

1. Be an engaged member of the leadership team and having an appropriate presence on the floor.

2. Ensure open lines of communication and clear messaging at all levels.

3. Interact with system end user, HSE, QA, QC, Process Control Engineering, Validation, TSMS, etc.

Staff Development and Management:

1. This position involves directly managing 4-6 Frontline Engineers.

2. Provide leadership, training, coaching, and effective career development for frontline engineers.

3. Conduct annual performance reviews with team members.

4. Ensure the company values, standards and policies are communicated to and modeled within the teams

5. Participate in Engineering succession planning.

Resource Management:

1. Fosters an inclusive workplace and engaged workforce.

2. Ensures effective hiring and staffing (right person for the right role).

Basic Requirements:

1. Bachelor of Science in Engineering discipline.

2. 5 years industrial experience in cGMP environment.

3. Knowledge of/experience with several biopharmaceutical processes, facilities, plant or utilities

equipment.

4. Strong organizational skills.

5. Must have experience in leading small/medium scale process improvement projects.

6. Must have the ability to function in a fast-paced environment and communicate effectively cross functionally with staff, and management (both written and verbal).

7. Sound problem solving and decision-making skills.

Additional Preferences:

1. Strong leadership skills.

2. Strong written and oral communication skills.

3. Self-directed personality, with ability to work independently, self-sufficiently and proactively in the performance of work duties.

4. Ability to resolve conflict and promote good decision making among team members.

5. Experience with various root cause analysis tools/techniques.

This role is exempt and the anticipated compensation for this role is $109,500 - $146,000.

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. This role requires up to 10% travel, on-call availability, and may involve shift work. 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.