Senior Engineer – Aseptic Facilities Design and Construction
Provide subject matter expertise on technical facility matters including HVAC, electrical, pneumatic, refrigeration, conveyor, hydraulic, and physical building systems. Participate in aseptic facility construction projects by reviewing technical aspects of contracts and ensuring proposals meet company objectives. Identify mechanical systems supporting critical operations, perform capacity and condition assessments, and implement projects to ensure uninterrupted operations activities. This position supports all compounding center locations, and is based in the corporate headquarters location in Lake Forest, IL.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Provide leadership and technical direction on facilities construction and improvement projects. Assess current state of clean rooms, buildings, and facilities systems implement improvements.
- Ensure critical compounding systems redundancy and capacity.
- Continually evaluate opportunities for facilities improvements.
- Ensure standardization of formal procedures and processes. Ensure compliance to local, state, and federal building standards.
- Develop capital and expense budgets. Monitor and control on a continual basis the expenditures for each budget.
- Develop and submit documentation to the Executive Team regarding current status of projects, compliance to schedules, strategic planning, and budget oversight.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- BS in Engineering or relevant technical discipline. M.S. in engineering field desired.
- Minimum of 5-8 years of facilities improvements or facilities design experience in medical device and/or pharmaceutical manufacturing (including 5-8 years of management experience).
- Aseptic facilities design and construction experience preferred.
- Familiar with FDA requirements for aseptic processing and for compounded sterile preparations.
- Familiar with FDA cGMP compliance, clean room design standards (ISO 14644), and local, state, and federal building requirements.
- Experience with engineering processes (project reporting, standard operating methods, and change control).
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- Innovative, decisive, results oriented contributor with strong coaching, problem-solving, and project management skills.
- Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions.
- Must be proficient in Microsoft Word, Project, Excel, and Outlook.
- Must be proficient in CAD software (AutoCAD).
- Strong organizational skills, lean knowledge preferred.
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