Spclst, Engineering

Job Description

This position will serve Building 50 and Building 51, and any other building that falls under the supervisory code SP‑05 or Planning group PL‑50. Our engineers support internal and external manufacturing operations, keeping them operational while continuously improving and innovating across diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation. We seek a growth‑oriented Engineering Maintenance & Utilities Specialist to help drive our strategic operating priorities.

The role will start on the first shift and establish the processes and systems needed to support the third shift for a new building. Workdays will be Monday through Friday, but the individual will also support Saturday and Sunday operations as needed.

• Provide technical manufacturing support in engineering, maintenance, and utilities (EMU).
• Offer day‑to‑day engineering support for assigned areas, which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and mechanical support utilities (power, HVAC, steam, WFI, CTU’s).
• Monitor equipment performance, propose and develop improvements, and troubleshoot process equipment to ensure reliable, compliant, and efficient operations.
• Actively ensure GMP quality, safety, environmental, and operating cost goals are achieved.
• Provide supervisory coverage as occasion requires.
• Collaborate with Operations, other EMU engineers, technology, maintenance supervisors, and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety, and environmental regulations.
• Champion the preventive and predictive maintenance program by reviewing equipment history, performing root cause analysis, and identifying reliability improvement opportunities.
• Develop maintenance and repair strategy for shutdowns.
• Assist or lead operations, maintenance supervisors, mechanics, automation engineers, process engineers, and quality representatives in troubleshooting equipment problems and investigating manufacturing atypical events related to system failure or malfunction.
• Serve as project engineer and manager for projects including scope development, design, walk‑downs, SAP PM data uploads, Pro Cal data uploads, field execution, and commissioning/qualification testing.
• Identify spare parts and standby equipment to ensure maximum capacity and reliability.
• Support maintenance scheduling and planning processes.
• Help ensure a safety culture and participate in HAZOP reviews and safety inspections.
• Promote open communications, inclusion, and teamwork.
• Author standard operating procedures or user manuals and assist in training development for mechanics and supervisors.
• Work with contractors and outside resources and ensure all safety and quality standards are met.
• Assist in the preparation of process studies, engineering standards, equipment utilization, and profit plans.
• Explain and enforce all GMPs, safety, and environmental regulations.
• Assist in audits, regulatory inspections, and training.
• Create, optimize, and manage the creation of job plans and knowledge management documents.

• Bachelor of Science in Engineering, Science, or Engineering Technology.

• Ability to work independently and as a team member with integrity, precision, accomplishment, motivation, and respect.
• At least 3 years in a manufacturing or technical support group or equivalent.
• Proficiency in empowering leadership, flexibility, motivation, teamwork/partnership, problem‑solving, communication, and computer skills.
• Knowledge of engineering standards such as ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI.

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing.
• Lean Six Sigma methodology.
• Root cause analysis and failure mode effects analysis.
• Knowledge of reliability engineering and asset lifecycle management.
• Experience with CMMS (Maximo, SAP, Hexagon, Pro Cal).
• CMRP certification.

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. We comply with all affirmative action requirements as a federal contractor.