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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, Facilities is responsible for all aspects of design, specification, installation, commissioning, qualification, and compliance of the facility and associated support systems and utilities at the POINT Indianapolis site. The position is based in Indianapolis, Indiana, U.S. and reports directly to the Manager, Facilities Engineering & Compliance. The position will observe typical business hours, Monday through Friday. Some evening or weekend work may be required on an occasional basis.

Responsibilities

• Support engineering capital and change projects through specification, costing, procurement, installation, commissioning, qualification and hand-over.
• Support the design, engineering, installation, commissioning, and qualification of facility equipment, utility and support systems, material handling equipment, wastewater management automation equipment, and building modifications.
• Support the preparation and review of URS, DS/DQ, FMEA, IQOQ documentation and protocols for new equipment.
• Maintain a detailed and expert knowledge of current and future innovative and diverse pharmaceutical platform technologies, with a strong emphasis in cleanroom environmental systems and facility control systems.
• Partner with maintenance and production stakeholders to assist in day-to-day troubleshooting of facility, utility and material handling related equipment issues as required.
• Provide engineering support for building management systems, including control and monitoring systems, ensuring 21 CFR Part 11 compliance for system monitoring and reporting.
• Provide technical engineering support to maintenance and other facilities personnel to facilitate timely response for maintenance and troubleshooting requests and engage in the continuous improvement initiatives of the company.
• Mentor fellow engineering, maintenance and technical stakeholders in mechanical and automation technologies and applications.
• Support the design, operation, and maintenance of our CMMS, BMS, Drawing Management and EMS at the site.

Requirements

Education and Experience

• Minimum Bachelors degree in Engineering or Science required. Focus in mechanical and electrical engineering is preferred. Advanced degree is preferred.
• Minimum 2 years of experience working as a facilities or equipment engineer supporting manufacturing, preferably in an FDA regulated operation such as the drug product, medical device, or food and beverage manufacturing industries.
• Experience working with small-volume parenteral, sterile unit-dose filling, or radiopharmaceutical drug product is preferred.
• Experience installing, commissioning and qualifying GMP systems.

Competencies

• Excellent verbal and written communications skills with technical or cross-functional audiences, and proven ability to work independently with external suppliers.
• 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.
• Ability to read and understand blue-prints, schematics, and other technical documents.

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.