Facility/Utilities Engineer
PharmaRegulatory AffairsQuality Assurancegmpemacroraveinformaws
Job description
Job Description We aspire to be the premier research-intensive biopharmaceutical company, and we're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to the performance and results of our utility department, focusing on mechanical system improvements and optimizations. The Facility/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 mechanical system improvements and optimizations. The incumbent will also be responsible for leading plant engineering improvement projects and implementation of productivity enhancement initiatives Responsibilities Manage individual contributors (professional employees) and/or contractors Contribute to the performance and results of the utility department Adapt departmental plans and priorities to address resource and operational challenges Make decisions guided by policies, procedures, and business plan; receive guidance from manager Provide technical guidance to employees, colleagues, or contractors Anticipate and interpret client and/or customer needs to identify solutions Work as a liaison between Plant Engineering and other Site Business Partners Manage capital projects involving plant engineering equipment replacement/upgrades Apply management skills to align work activities with department objectives 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 and provide necessary training for system maintenance as a subject matter expert (SME) Work alongside operations and lean six sigma team members to develop reliable utility processes that meet cGMP requirements Be 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 Identify and resolve technical and operational problems; collaborate with peers to resolve problems that cross into inter-related units Assist in the identification, development, and implementation of new systems which enhance the operation of Plant Engineering processes Assist with troubleshooting Plant Engineering utility equipment on an as-needed basis, including but not limited to chillers, boilers, AHUs, PLCs, humidifiers/dehumidifiers, water systems, Square D controllers/monitors, clean steam generators, and electrical distribution systems Conduct engineering tasks as needed to maintain plant utility equipment Explain difficult concepts and persuade others to adopt point of view; communicate information, ask questions, and check for understanding Be accountable for the performance of plant engineering systems Make decisions guided by policies, guidelines, and procedures that impact the department’s ability to meet performance objectives; consult on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes Adapt and implement departmental plans and priorities based on division scorecards to address local business, service, and operational challenges Consult on an as-needed basis with next-level manager for newly identified priorities Forecast resource needs; manage allocated expense budgets and allocated resources to implement projects Qualifications Required Bachelor of Science (BS) in engineering or technology (Other fields in scientific disciplines can be considered provided the candidate has strong, relevant, and direct work experience) Five or more (5+) years of facility/utility experience Familiarity with cGMPs and regulatory requirements Problem solving and troubleshooting skills Technical writing and deviation investigation skills Utility, HVAC, and Refrigerant system process improvement and optimization experience Preferred cGMP experience in a pharmaceutical environment Formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools Knowledge of Mechanical, Plumbing, ASME, and NFPA code requirements Five or more (5+) years of industrial mechanical experience (HVAC, Boilers, Chillers, Cooling Towers, Refrigeration, Air Compressors, Air Dryers, and Hot Water Skids) Automation (BAS) experience Deviation management, troubleshooting, and resolving manufacturing anomalies Minimum three years of supervisory or project management experience Required Skills: Adaptability, Adaptability, Budget Estimating, Capital Project Management, Change Management, Competency Management, Corrective Action Management, Data Analysis, Deviation Management, Equipment Qualification, Facility Engineering, Facility Management, Good Manufacturing Practices (GMP), Influencing Skills, Liaison Work, Maintenance Supervision, Occupational Safety and Health, Plant Engineering, Plant Management Software, Problem Identification, Process Improvements, Project Resource Management, Regulatory Audits, Regulatory Management, Resource Allocation {+ 9 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: <a href="https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf" target="_blank"
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