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POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein- (FAP-), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

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 Bachelors 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 today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

Benefits

• Eligible for annual incentive bonus plans and stock options
• Health Care Plan (Medical, Dental & Vision) 85% paid by employer and effective day 1
• Retirement Plan (matching 401k)
• Income Protection Insurance (Life AD&D, Short & Long-term disability) 100% employer paid
• Voluntary Income Protection Premiums paid by employee
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement per year
• $100 cell phone reimbursement per month

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.