Manager-Plant Engineering

About the role

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.

Responsibilities

• Manage team of plant engineers providing Front Line engineering support in the following areas: a. Plant Engineering: Clean Utilities, Grey Utilities, HVAC, Chambers, Electrical.
• Provide coaching/assistance to Front Line Engineers, but also help drive continuous improvements, support capital delivery, among other key strategic initiatives.
• 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.
• Makes decisions guided by engineering standards and policies, procedures and business plan that impact the ability of the Plant Engineers to meet performance objectives.
• 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.
• Ensure continuous improvement mindset for process and operational improvements.
• Apply statistical thinking and methods to understand process variability and capability and drive improvements.
• Support regulatory inspections.
• 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.
• Establish control systems to monitor, trend and verify equipment performance and downtime. Identify and optimize unit operation cycle time, loading, yield performance, etc.
• Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized.
• Develop, review and approve technical documentations such as SOPs, batch records, investigations, etc.
• Present and attend various governance teams to represent process/plant engineering.
• Support commissioning and qualification activities.
• Be an engaged member of the leadership team and having an appropriate presence on the floor.
• Ensure open lines of communication and clear messaging at all levels.
• Interact with system end user, HSE, QA, QC, Process Control Engineering, Validation, TSMS, etc.
• Provide leadership, training, coaching, and effective career development for frontline engineers.
• Conduct annual performance reviews with team members.
• Ensure the company values, standards and policies are communicated to and modeled within the teams.
• Participate in Engineering succession planning.
• Fosters an inclusive workplace and engaged workforce.
• Ensures effective hiring and staffing (right person for the right role).

Requirements

• Bachelor of Science in Engineering discipline.
• 5+ years industrial experience in cGMP environment.
• Knowledge of/experience with several biopharmaceutical processes, facilities, plant or utilities equipment.
• Strong organizational skills.
• Must have experience in leading small/medium scale process improvement projects.
• Must have the ability to function in a fast-paced environment and communicate effectively cross functionally with staff, and management (both written and verbal).
• Sound problem solving and decision-making skills.

Skills

• Strong leadership skills.
• Strong written and oral communication skills.
• Self-directed personality, with ability to work independently, self-sufficiently and proactively in the performance of work duties.
• Ability to resolve conflict and promote good decision making among team members.
• Experience with various root cause analysis tools/techniques.

Pay

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.

Benefits

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.

Schedule

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.