• This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting
• This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations
• The incumbent will also be responsible for leading plant engineering’s sustainability improvement projects and implementation of productivity enhancement initiatives
• Individual contributor role working with professional employees and/or contractors
• Contributes to the performance and results of the department
• Manage the Durham Site's Sustainability portfolio in its entirety involving any of the following:
• Regulatory compliance with internal interpretations
• Manage project strategy for the Durham Site to achieve Net Zero goals based on sustainability Mater Plan
• Develop Business case for sustainability projects to ensure appropriate return in financial and emissions reductions
• Determine execution strategy for each
• Develop project execution plan for main components all requirements of the program involving above site commitments and site level commitments
• Perform ongoing monitoring of systems and ensure returns are being achieved
• Report on and run governance meetings to manage the program, solicit help and ensure targets are met
• Execute tasks within the program to achieve plan developed
• Work with third party vendors and engineering firms to assist in development and completion of any tasks related to program support
• Perform other maintenance and departmental tasks as required for success like maintenance plan updates, SOP/SBP draft and updating, drawing support, etc
• Adapts departmental plans and priorities to address resource and operational challenges
• Decisions are guided by policies, procedures and business plan; receives guidance from manager
• Provides technical guidance to employees, colleagues or contractors
• Anticipates and interprets client and/or customer needs to identify solutions
• Works as a liaison between Plant Engineering and other Site Business Partner’s
• Team member for small capital projects for plant engineering
• Obtains bids, reviews contracts, supervises, and follows-up on contract work including
• Actively Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns
• Coordinates with Site Engineering and IPT production planners
• Attends daily shutdown meetings ensuring owned activities are tracked and completed
• Participate in cross-functional teams for engineering Operations projects, or other plant activities as needed
• Works to streamline and improve Maintenance department systems, procedures and ways of working with a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency
• Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals
• Work hands on to troubleshoot and understand Sustainability impact to the site & utilities systems and equipment issues around the site
• Applies skills to align work activities with department objectives
• Project management (manages project priorities – schedule & cost, installation)
• Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up-time, minimizing cost and maintaining process consistency

Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment

• Develop training material
• Working as a subject matter expert (SME), provide necessary training for system maintenance
• Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements
• PROBLEM SOLVING:
• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
• The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving
• Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes

Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage

• Perform engineering task as needed to maintain plant utilities equipment
• Explains difficult concepts and persuades others to adopt point of view
• Communicates information, asks questions and checks for understanding
• Provide clarification in person and in writing for streamlined communication
• Accountable for the their own performance and performance of sustainability program & support of plant engineering systems and maintenance
• Makes decisions – guided by policies, guidelines, design practices, and procedures – that impact the department’s ability to meet performance objectives
• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes
• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
• Consults on an as-needed basis with next-level manager for newly identified priorities
• Lead initiatives and see through to completion
• Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals
• Utilize maintenance and reliability metrics and key performance indicators
• Benchmark performance indicators against industry data
• Look for continuous improvements opportunities
• Forecasts resource needs; manages allocated expense budgets for tasks
• Forecasts resource needs; manages allocated resources to implement projects
• Working Relationships
• Reports to Plant Engineering Manager
• Frequent interaction with employees from other departments
• Interacts with representatives from regulatory agencies
• Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment

Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures

• Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities
• Assists in deviation investigations for maintenance instruments, equipment, and systems

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Extensive industrial experience involving utility system generation, distribution and controls are needed
• Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)
• Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service
• Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment
• Bachelor’s Degree in Engineering, Science or related field
• Five years of experience in a production and/or calibration and/or maintenance background
• Strong planning, scheduling, and time management skills
• Good oral and written communication skills
• SAP experience related to plant maintenance and spare parts procurement systems
• Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools
• Familiarity of “World Class” maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)
• Utility and HVAC system process improvement and optimization experience
• Technical writing and deviation investigation experience
• Experience in managing a project portfolio and/or a program with strategic initiatives
• Experience in problem solving and troubleshooting

Familiarity with cGMPs and vaccine regulatory requirements

• Engineer must be have in depth experience (without further skills training) working with industrial utility generation equipment – Boilers, Chillers, Compressors, Pumping distribution systems, etc

The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures

• Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities – Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment

Accountability, Accountability, Adaptability, Capital Project Management, cGMP Regulations, Change Management, Communication, Curriculum Development, Data Analysis, Engineering Processes, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Leadership, Maintenance Supervision, Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Regulatory Compliance, Sterile Manufacturing, System Maintenance, Team Leadership, Third Party Vendors {+ 1 more}

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days