Senior Automation Engineer

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

Reporting to the Vice President, Facilities and Engineering, the Senior Automation Engineer is responsible for the design, management, troubleshooting, and maintenance of a variety of automation platforms that are used to monitor and control process and utility equipment, engineering, and facility systems. The Senior Automation Engineer serves as the company's subject matter expert in the automation for all commercial manufacturing processes and equipment. The Senior Automation Engineer also ensures that equipment/automation platforms are in-control, compliant, and capable of meeting customer needs, while delivering on projects associated with regulatory compliance, commercialization and continuous improvement efforts.

Responsibilities:

• Manage multiple projects or initiatives of varying complexity and size.
• Apply expertise in automation engineering practices to perform a wide variety of troubleshooting and maintenance activities for on-site equipment and systems.
• Support all of the site's PLC based Process Control Systems (Siemens and AB), HMIs, building management system, and environmental monitoring system.

• Establish and monitor/trend control systems for verifying and optimizing equipment and system performance.
• Provide control system hardware and instrumentation requirements, perform design review, vendor/contractor selection, constructability reviews, approval of submittals, and prepare and oversee validation and regulatory submissions.
• Possess strong knowledge of computer system validation and related practices, including GMP, GAMP and 21 CFR Part11 requirements.
• Oversee requirements gathering, design, configuration, integration and implementation of process control solutions for manufacturing including batch software, PLC / DCS systems, HMI packages, SCADA systems, Visual Basic and PC networking technology.
• Prepare engineering standards, approve submittals, author SOPs, Qualification, Validation and Commissioning Protocols, and conduct on-site start up and training for new equipment.

• Work collaboratively with internal Manufacturing, Facilities, and Quality Teams, and manage external resources, including vendors, consultants, and contractors.
• Provide process control engineering focusing on process optimization, risk mitigation, and compliance improvements.
• Author or review and approve automation system lifecycle design documentation (user requirements, functional and design specifications, system integration, commissioning, and qualification protocols).
• Author and manage complex Change Control plans and documents.
• Lead investigations of complex deviations and support implementation of corrective and preventative actions (CAPAs).
• Perform root cause analysis and risk assessment processes.
• Demonstrate strong leadership qualities and provide technical direction to other engineers.

Requirements

Education and Experience:

• Minimum of 8 years of automation industry experience
• Minimum of 5 years of experience in a GMP pharmaceutical environment
• Proven programming experience with PLCs and HMIs (including Allen-Bradley/Rockwell and Siemens) and knowledge of process manufacturing field instrumentation
• Proven experience with Building Management Systems
• Expert knowledge of engineering principles and concepts
• Extensive knowledge of GMP requirements as well as commissioning and qualification practices in a pharmaceutical environment
• Possesses strong knowledge of regulatory requirements related to GMP, GAMP, CFR 210, 211, Part 11

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.
• Strong communication and computer skills.
• Must lead by example through strong work ethics and high standards.

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.