Reliability Engineer - Insight Global : Job Details

Required Skills & Experience:

Bachelor Degree in Engineering

• 5+ years' experience in GMP Manufacturing
• Experience working with a Drug Product Line
• Experience with Filling Line equipment:

-vial washer

-Depyrogenation tunnel

-vial filling line

-loading & unloading automatic table

-isolator

• Proven experience with FMEA methodology
• Good technical writing skills
• Experience writing job plans & SOPs

Nice to Have Skills & Experience:

• Optima Filling Line Equipment
• Familiarity with maintenance practices and spare parts management

Job Description:

One of our large pharmaceutical clients is actively hiring a consultant to support a new state of the art vial filling drug manufacturing facility, specifically to focus on the Optima Filling Lines. This team supports engineering, maintenance, and utilities including troubleshooting, setting up equipment, vendor documents, & operating and keeping the equipment running. The ideal candidate will be responsible for developing job plans through conducting Failure Modes and Effects Analysis (FMEA), gathering essential data, and ensuring that all aspects of the filling line operations, maintenance, and training are met. This role involves significant collaboration with various stakeholders, including Subject Matter Experts (SMEs), equipment vendors, and maintenance staff to enhance the efficiency and reliability of production processes associated with the Depyrogenation Tunnel, Vial Washer, Vial Filling Line, Loading and Unloading Tables (LUATs), Garvey Conveyors, Vial Cappers, and associated components. Key Responsibilities: FMEA Development: - Conduct thorough FMEAs to identify and evaluate potential failure modes associated with filling line equipment. - Gather and assess necessary documentation such as P&IDs, O&M manuals, validation protocols, and operating procedures. Data Collection and Analysis: - Conduct visual walkdowns and interviews with SMEs, equipment vendors, and maintenance personnel to gather insights and information Job Plan Creation: - Develop comprehensive job plans that incorporate findings from FMEAs and data collection efforts. - Design and document maintenance strategies that ensure the optimal performance of filling line equipment. Spare Parts Management: - Review and maintain an inventory of spare parts, ensuring availability for critical components. - Create and maintain Bill of Materials (BOMs) for all relevant systems and components. Training Development: - Create effective training documents and materials for maintenance and operational staff pertaining to the filling lines. - Conduct training sessions to ensure all team members are knowledgeable about equipment maintenance and operational procedures. This role is fully onsite in West Point, PA.