Plant Engineer, Process Utilities

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

The role of Plant Engineer, Process Utilities is to ensure the reliable and compliant operation of essential support utilities (such as Clean-in-Place (CIP), glycol, compressed air, process gases, and process waste). As a key part of the Plant Engineering team, this engineer will execute projects to improve the safety, efficiency, reliability and compliance of these utility systems. They will oversee maintenance activities, coordinate system shutdowns, provide troubleshooting know-how, and lead investigations related to these systems. Members of this team serve as subject matter experts (SMEs) for these systems on project teams and during regulatory inspections. The members of this team are expected to cross-train on facility systems, but each individual will maintain specialized skill. The role will report into the Senior Manager of Plant Engineering.

Duties & Responsibilities

• Primarily responsible for manufacturing utility systems including glycol, process waste, clean-in-place (CIP), compressed air, process gases, and others.
• Issue or contribute to safety permits and job hazard analyses (JHAs) to ensure the safe execution of projects or maintenance activities.
• Manage engineering projects to improve plant utility systems. Seek out and apply novel engineering approaches.
• Coordinate projects and maintenance activities with operations to minimize disruption.
• Provide technical guidance for maintenance technicians, outside service providers, and operations users.
• Engage with Facilities & Engineering (F&E) internal partners and external resources to engineer solutions.
• Review and approve drawings and other technical documentation to ensure that it remains current.
• Ensure compliance of cGMP critical utilities with cGMPs, industry best practices, and LOTTE Biologics directives.
• Investigate adverse trends and implement corrective actions.
• Create or contribute to quality plans that ensure orderly service interruptions and smooth return to service.
• Collaborate with other functions such as quality assurance and safety to resolve compliance issues.
• Remain informed about the current industry practices and guidelines for critical utilities.
• Respond to unplanned outages to minimize disruption to manufacturing operations.
• Serve as a site SME for critical utility systems and interact with regulatory authorities or internal auditors. Ensure inspection-readiness of key systems. Develop responses and action plans to correct any deficiencies.
• Leverage appropriate resources from our site integrated facilities management (IFM) provider.
• Identify continuous improvement, energy conservation, and cost savings opportunities.
• Apply modern reliability concepts to ensure effective maintenance and prevent failures.
• Maintain and revise standard operating procedures (SOPs) governing system operation and maintenance. Train in-house technicians and contractors as required.
• Provide on-call, off-hours support as needed to assist with planned activities or respond to unplanned problems.
  
  

Education & Experience

• BS Degree in Engineering or related discipline required. Mechanical or Chemical Engineering preferred.
• Relevant utilities engineering experience is required. Knowledge of pharmaceutical utility operation, cleanrooms, HVAC, pharmaceutical water systems and building systems is preferred.
• Established ability to work across organizational boundaries to resolve a range of technical and compliance issues.
• Understanding of applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs).
  
  

Work Environment

• Must be willing and able to work overtime, be on-call and be available to work off-shifts
• Inside Work; Working Alone; Working With/Around Others (Frequently)
• Outside Work; Noise =or>85 dBA (with hearing protection) (Occasionally)
• Extremes (heat); Confined Spaces; Cramped Quarters; Heights; Dust/Mist/Fumes/Wet; Damp/Walking or Work Surfaces; Chemicals (Infrequently)
  
  

Physical Demands

• Lifting of Items, Not to Exceed 50lbs; Bending/Stooping; Twisting; Crouching/Squatting; Sitting; Walking-Level Surfaces; Repetitive (use of arms, hands, wrists); Grasping; Fine Manipulation; Operates Vehicle; (Frequently) Kneeling; Reaching and Working Overhead (shoulder); Use of Foot Control; Vision (acuity, color-correction allowed) (Occasionally); crawling.
  
  

Supervisory Responsibilities

• Supervision may include FTEs and contractors, including objective setting for the department.
  
  

Travel

This position requires up to 5 % of travel.

New York Pay Range

$76,000—$113,000 USD

Work Location

East Syracuse, NY

We are an Equal Employment Opportunity ("EEO") Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!