The Manufacturing Engineer performs engineering, maintenance, and metrology activities for the company. Maintains the systems and performs the job functions by which equipment, instruments, facilities and processes are designed and implemented. Manages the procurement of facilities and equipment related purchases and executes engineering studies and associated resources.
Essential Job Functions:
• Daily / Weekly Tasks
o System daily/weekly checks (water systems, compressed air systems)
o Performs and/or coordinates scheduled calibrations and Preventive Maintenance (PM)
o Updates Calibration and Equipment Databases with completed PMs and calibrations
o Generates Calibration and Equipment Database reports
o Equipment Qualifications and Re-qualifications
• Monthly Tasks
o Datalogger download and chart printouts
o Particle counts
o Water system performance checks
• Quarterly Tasks
o Scale and balance calibrations
• Semi-Annual Tasks
o Water system RO sanitizations and UV light maintenance
o Air compressor maintenance
• Annual Tasks
o Water system distribution loop sanitizations
• Air compressor maintenance
• Manages engineering projects, which will encompass equipment, facilities, utilities and processes
• Determines current engineering needs and plans for future engineering requirements
• Plans and executes the workload within the department to meet priorities
• Serves as an engineering expert for the site
• Reviews and approves engineering documentation
• Manages and/or participates on cross-functional project teams
• Manages the continuous engineering improvement process for the equipment, facility, utilities and processes
• Foster a team-based spirit of enthusiasm, while being results oriented
• Responsible for the proper handling, inventory control, processing, or analysis of narcotics and other controlled substances in accordance with company policies and procedures
• Ensures policies, legislation and procedures are adhered to: including company SOPs, 21 CFR Part 11 and Sarbanes-Oxley (SOX) compliance, as appropriate to position
• Performs other related duties as required
Knowledge and Skills Required:
Education: Minimum of a Bachelor's degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Electrical Engineering and/or Manufacturing Engineering is required.
Experience: 1-3 plus years of experience in a manufacturing or processing environment in an FDA-regulated industry performing engineering or engineering related activities.
Mathematical: Must be able to perform engineering calculations. Must be able to analyze data using statistical tools. Must be capable of developing capital projects and expense budgets.
Language: Ability to read, comprehend, and communicate instructions and written procedures. Ability to review and revise documents with proficient grammar and spelling skills . Ability to write routine reports and correspondence. Ability to speak effectively before groups.
Reasoning: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form . Ability to deal with problems involving several concrete variables in standardized situations. Able to analyze data and generate conclusions based upon the data. Ability to read specifications and determine test plans.
Computer: Proficient to advanced skills . Must be fluent in word processing, spreadsheets, email, and project management programs. Ability to use Microsoft Access and Microsoft Project, Statistical Programs, such as Minitab and AutoCAD.
Well-lit, heated and/or air-conditioned indoor laboratory setting or office environment with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature
Supervision / Supervisory Responsibilities:
Ability to deal confidently and effectively with all subordinates, superiors, and colleagues including vendors and customers at different levels.