Plant Engineer (HVAC)

Plant Engineer (HVAC)

RESPONSIBILITIES

• 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 in order to minimize disruption.

• Provide technical guidance for maintenance technicians, outside service providers, and operations users.

• Engage with Facilities & Engineering (F&E), Global Engineering, 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, industry best practices, and BMS 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 or safety to resolve compliance issues.

• Remain informed about the current industry practices and guidelines for critical utilities.

• Respond to unplanned outages in order 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.

QUALIFICATIONS

• Bachelor of science degree 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.

• Strong technical knowledge in a focus area such as pharmaceutical water systems, HVAC, or electrical engineering.

• 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.