Associate Engineer, CMMS

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

The Associate Engineer, CMMS is primarily responsible for the design, delivery, operation, and continuous improvement of our Computerized Maintenance Management System (CMMS) along with associated processes and procedures at the POINT Indianapolis site in support of GMP manufacturing. In addition to their primary responsibilities, the Associate Engineer, CMMS will provide oversight to contracted resources for the delivery of our new CMMS. The position is based in Indianapolis, Indiana, U.S. and reports directly to the Manager, Engineering & Compliance. The position will observe typical business hours, Monday through Friday. Some evening or weekend work may be required on an occasional basis based on project schedules.

Responsibilities

• Coordinates and supports implementation and on-going validation associated with the CMMS.
• Implements and maintains procedures for maintenance (preventive and corrective) and calibration of all assets to include non-GMP and GMP equipment, lab equipment, and utilities. Utilities include GMP water systems, compressed gases, HVA systems, electrical, life safety, radiation safety, and emergency power systems.
• Serves as the lead administrator of the CMMS controlling user access list and rights/permissions.
• Develops and maintains the processes associated with the addition or retirement of assets within the CMMS system.
• Owns the management of spare parts throughout the facility.
• Leads the communication of, planning, and scheduling of all preventive maintenance and calibration activities.
• Utilizes the CMMS to manage work orders, track equipment history, and analyze maintenance data to improve equipment performance and reliability.

• Collaborates with cross-functional teams, including QA, Engineering, and Production, to develop and implement validation protocols, ensuring the qualification and validation of equipment, processes, and systems.
• Assists in managing and executing change control processes, ensuring proper documentation, review, and approval of changes to equipment, processes, and systems.
• Supports the development, implementation, and continuous improvement of standard operating procedures (SOPs), work instructions, and maintenance best practices.
• Coordinates with QA to ensure timely resolution of audit findings and implementation of corrective actions related to maintenance activities.
• Coordinates with vendors, suppliers, and OEMs for the execution of work and requisition of parts.
• Participates in ongoing training and development to maintain current knowledge of cGMP regulations, industry best practices, and emerging technologies.

Requirements

Education and Experience

• Minimum Bachelor’s degree in Engineering or Science required. Focus in mechanical, electrical, or chemical engineering is preferred.
• Minimum 2 years of experience working as an engineer in an FDA regulated operation such as the drug product or medical device manufacturing industries.
• Experience working with or the administration of a CMMS and/or managing assets.

Competencies

• Understanding of OSHA safety practices.
• Demonstrated ability to excel in a collaborative team environment.
• Ability to plan, develop and execute multiple projects under tight timelines.
• Excellent organizational and interpersonal skills.
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel).
• Manage multiple projects, set priorities, and work in a fast-paced environment.
• Great attention to detail.

Why joining POINT toda