Equipment Specialist

Job Responsibilities: 

• Resolve issues that arise in day to day running of operations and provide timely responses and solutions
• Function closely with operations personnel to understand their interaction with equipment and resolve issues they face
• Implement solutions in collaboration with cross-functional technical teams and site leadership team
• Support filling equipment, formulation process, visual inspection equipment, and/or labeling process.
• Evaluate and improve the efficiency of manufacturing instruments, equipment, and tools
• Evaluate and implement new changes
• Support operations through standard operating procedure revision
• Participate and/or support process FMEAs to understand process and product risks
• Provide technical support to manufacturing activities
• Work flexible hours to ensure production facility coverage
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Qualifications:

• Bachelor Degree in an Engineering field or Bachelor's Degree in life sciences
• 3+ years of relevant work experience, work experience considered in lieu of education
• Lean Six Sigma Certification
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), visual inspection, and labeling