LOTTE BIOLOGICS located in East Syracuse, NY is seeking a Plant Engineer, Critical Utilities to join our team who entered the biologics Contract Development Manufacturing Organization (CDMO) business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site on January 1, 2023!

The Plant Engineering team is responsible for the compliant operation of GMP critical utilities (such as cleanroom HVAC, high-purity water systems, and process gases) and the reliable operation of essential support utilities (such as glycol, compressed air, and process waste). This group executes projects to improve the safety, efficiency, reliability, and compliance of these systems. They oversee maintenance activities, coordinate system shutdowns, 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 everyone will maintain specialized expertise.  The Pharma Water Systems Plant Engineer is also responsible for leading and managing the Critical Utility Technicians, who maintain and operate the water systems. 

Responsibilities:

• This position will have primary responsibility for pharmaceutical water systems, including water for injection (WFI), reverse osmosis (RO), de-ionized water systems (DI), and clean steam.
• 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) and external resources to engineer solutions.
• Review and approve drawings and other technical documentation to ensure that it remains current.
• Ensure compliance of GMP critical utilities with GMPs and industry best practices.
• 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 or 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.

Leadership:

• Responsible for the performance of all reporting team members. Takes an active role in developing less experience team members. Leverages both internal and external relationships to build the best team possible.
• Prioritize resources/activities for Critical Utility Technicians.
• Provide coaching, mentoring, and development of staff. Conducts powerful conversations and provides meaningful and actionable feedback for staff growth and development.
• Executes all phases of the performance review process with diligence and on time.
• Demonstrates ability to lead functional team to achieve objectives.

• Minimum of Bachelor of Science degree in Engineering - preferably Chemical or Mechanical.
• Minimum of 2-5 years relevant professional experience, preferably in Engineering.
• Knowledge of pharmaceutical utility operation, cleanrooms, and building systems.
• Experience with (or ability to learn) Maximo CMMS, Ariba purchasing, and SAP cost center functions.
• Demonstrated ability to work across organizational boundaries to resolve a range of technical and compliance issues.
• Experience safely managing multiple projects and balancing priorities.
• Strong analytical and problem-solving skills, especially as applied in a team environment.
• Willingness to provide on-call, off-hours support as needed to assist with planned activities or respond to unplanned problems.
• Understanding of applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs).
• Familiarity with modern maintenance management and reliability concepts.
• Ability to compose sound technical and compliance documents, including thorough investigations, meaningful corrective action plans, and justifiable change controls.
• Ability to articulate complex technical issues and communicate in a variety of forums to stakeholders and site leadership.
• Experience working in a GMP environment is a plus.
• Previous managerial experience is preferred.

Work Location:

• East Syracuse, NY

http://www.lottebiologics.com/

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.