Job Description

Job Description

Job Description

Job Title: Maintenance & Calibration Technician

Location: 8910 Purdue Road Suite 250 Indianapolis IN 46268

Duration: 05 Months

Type: Temp to Permanent (Assessed based on Performance criteria)

The working shift will be adjusted (1st or 2nd) after initial onboarding and training completion.

Job Description Summary:

• The Maintenance and Calibration Technician is responsible for performing corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. Responsible for reliable, efficient, and sustained operation of the facility and all equipment.

• Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.

The working shift will be adjusted to second shift after initial onboarding and training completion.

Major Accountability:

• Adhere to Client Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality.

• Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems.

• Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision.

• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.

• Support 24x7 site-based operations after startup.

• Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems.

• Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment

• Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System

• Supply information and technical data for securing spare parts.

• Provide responsive customer support with emphasis on customer satisfaction.

• Perform startup and commissioning activities as required.

• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs

• Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment.

• Complete and provide accurate documentation, as required in cGMP operations.

• Oversee work and provide training of less experienced maintenance technicians and/or new technicians.

• Other related duties as assigned.

• Use of CMMS system for documentation of relevant work.

Minimum Requirements:

• High School diploma or equivalent is required; Bachelor's Degree is preferred.

• 5+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required.

• Previous aseptic fill/finish and/or radio pharmacy experience is preferred.

• Previous pharmaceutical or medical device experience is preferred.

• Completed training in radioactive or hazardous materials environment is preferred.

• Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)

• Experience working in a team environment, with excellent communication and organizational skills.

• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system.

• Ability to climb ladders and lift up to 50 lbs.

• Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments.

• Must be flexible to work nights, weekends, and holidays as required.

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