Senior Specialist, Engineering

Overview

The Sr. Facilities/Utilities Engineer is a member of the Plant Engineering team providing technical support to the Wilson Site. The site includes an Energy Center, Vaccine Manufacturing Facility, Quality Labs, and a Packaging facility. This support position will focus on investigation of utility/facility system excursions, system improvements and optimizations. The incumbent will also be responsible for leading plant engineering improvement projects and implementation of productivity enhancement initiatives.

• General
  • Manages individual contributors (professional employees) and/or contractors
  • Contributes to the performance and results of the utility department
  • Adapts departmental plans and priorities to address resource and operational challenges
  • Decisions are guided by policies, procedures, and business plan; receive 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 Partners
  • Manages capital projects involving plant engineering equipment replacement/upgrades
• Business and Functional Expertise
  • Apply management skills to align work activities with department objectives
  • Project management
  • Extensive industrial experience involving utility system generation, distribution and control are needed
  • Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost, and maintaining process consistency
  • Investigate deviations (both minor and major), with responsibility to interface with Operations, Automation, and Quality approvers
  • Perform a thorough review of engineering records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process
  • 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 utility processes that meet cGMP requirements
  • Knowledgeable of all utility systems (e.g. USP water, HVAC, electrical distribution, etc.) regarding functionality of equipment and relied on as SME during regulatory discussions
• Problem Solving
  • Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
  • Strong problem-solving skills and a direct involvement approach to problem solving
  • Candidate should be able to examine an issue from diverse perspectives to best understand and identify root cause
  • Assist with trouble shooting Plant Engineering utility equipment on an as needed basis including chillers, boiler, AHUs, PLCs, humidifiers/dehumidifiers, water systems, Square D controllers/monitors, clean steam generators and electrical distribution systems
  • Conduct engineering tasks as needed maintaining plant utility equipment
• Impact
  • Influence and effectively communicate concepts; check for understanding
  • Accountability for the performance of plant engineering systems
  • Decision making guided by policies, guidelines, and procedures; consult with next-level manager on more complex decisions affecting other units
• Strategic Planning | Resource Management
  • Adapts and implements departmental plans and priorities based on division scorecards to address local business, service and operational challenges
  • Consults on an as-needed basis with next-level manager for newly identified priorities
  • Forecasts resource needs; manages allocated expense budgets and allocated resources to implement projects

• BS in engineering or technology; other fields in scientific disciplines can be considered provided the candidate has strong, relevant, and direct work experience

• Five years of facility/utility experience
• Familiarity with cGMPs and regulatory requirements
• Problem solving and troubleshooting
• Technical writing and deviation investigation
• Industrial Electrical, Utility, and HVAC system process improvement and optimization

• cGMP in a pharmaceutical environment
• Formal problem-solving techniques, such as root cause analysis (RCA), FMEA, and/or Lean Six Sigma
• NFPA code requirements
• 5 years+ industrial electrical distribution
• Automation (BAS)
• Deviation management, troubleshooting and resolving manufacturing anomalies
• Minimum three year supervisory or project management

• Reports to Associate Director of Engineering
• Manages and interacts with employees within own department
• Frequent interaction with employees from other departments
• Interacts with representatives from regulatory agencies

Budget Management, Capital Project Management, Change Management, Curriculum Development, Data Analysis, Deviation Management, Equipment Qualification, Facility Management, GMP Compliance, Good Manufacturing Practices…