Equipment Engineer

Contact Me Directly: Grinil Khanna - grinil at ranitherapeutics dot com

Description

The Equipment Engineer is responsible for planning, coordinating and directing the operations of all equipment for effective calibration, maintenance and repair programs. This position organizes the arrangements for technical evaluation of equipment, purchase orders, planning, and scheduling of all calibration and preventive maintenance activities internally and by outside approved suppliers. Reviews and tracks the records, inspections, calibrations, and service agreements for the organization's equipment and tools. The position acts as a technical advisor on all equipment issues and technical feedback to the management team with equipment including but not limited to use, budgets, and potential equipment purchases. This position works closely with all Rani departments to ensure adherence to the Rani Equipment Calibration and PM procedures.

Requirements

• Update calibration and PM procedures and forms within the Quality Management System as needed
• Review all equipment specification information for completeness and appropriateness for the usage of the equipment
• Qualify equipment to ensure the fulfillment of all requirements including IQ/OQ validation and verification activities. Ability to create and execute quality documentation for internally and externally designed production equipment
• Determine troubleshooting, maintenance, and calibration procedures for each piece of equipment and train relevant personnel to perform them. Participate in troubleshooting and repair of test equipment as required
• Thoroughly document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
• Initiate equipment specifications for calibration information by collaborating with equipment owners, such as calibration parameters, tolerances and intervals
• Developing detailed reports or instructions to show how to calibrate/PM a new machine
• Review equipment specifications for the appropriateness of all preventive maintenance requirements
• Manage and maintain equipment database and equipment files
• Ensure appropriate labels are affixed to the equipment and tools, such a “No Calibration or PM Required”
• Collect, report, and monitor calibration/PM performance metrics monthly and report to the QA management
• Ensures scheduling of outside sources in accordance with established calibration frequencies and initiating supplier approval process if needed
• Coordinates with equipment owners and departments to issue and control all scheduled equipment due for calibration and PM and ensure to communicate the risks of possible scheduling challenges
• Ensures and verifies that any calibration/PM service providers are approved suppliers per Rani procedures
• Monitor CAL/PM schedule to ensure necessary equipment is properly calibrated/PM’ed in a timely manner
• Review all calibration and preventive maintenance records and certificates for accuracy and completeness, as per internal procedures.
• Initiate an NCMR and report any out of tolerance (OOT) results, represent QA on investigation and NCMR closure
• Responsible to secure inactive equipment/tools in designated storage area and archiving the corresponding files
• Any projects or tasks assigned by management

Education and/or Job Experience

• BS in engineering degree and/or related certifications
• A minimum of three years of equipment management experience with a working knowledge of equipment qualification, calibration and PM procedures and practices.
• Three years of related experience in an FDA regulated industry is preferred
• Must have knowledge of metrology skills including a sound understanding of dimensional tolerances and usage of precise mechanical measurement instruments
• Must demonstrate ability to be accurate and identify procedural inaccuracies and make recommendations for ongoing improvements and effectively implement changes
• Must demonstrate ability to work independently, make effective decisions, and resolve technical issues
• Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization across all departments and proactively identify issues and recommendations improvements
• Must demonstrate the ability to work effectively in teams to achieve results
• Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred

Skills and Specifications

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
• Flexible and adaptable to changing environment and priorities

Contact Me Directly to apply: Grinil Khanna - grinil at ranitherapeutics (dot) com

Rani Management is an equal opportunity employer. This means that Rani Management is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.