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Catalent Pharma Solutions Lead Automation Engineer in Bloomington, Indiana

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Lead Automation Engineer

The Lead Automation Engineer will support the Drug Substance Cell Culture and Purification operations team as a system owner of various process and process support control systems. As a system owner, the Senior Automation Engineer’s primary duty is to effectively maintain reliable and qualified operation of various Distributed Control Systems, Programmable Automation Controllers, Human Machine Interfaces, and Supervisory Control and Data Acquisition systems for both existing and new assets. Responsibilities include designing automation software and strategies based on the latest GAMP guidelines, developing software modules and graphical user interfaces in accordance with design requirements, trouble-shooting, improving and implementing automated control systems, compiling/maintaining automation requirements and design specifications, and interfacing with manufacturing and other end users of the system and implement necessary changes to improve system’s overall efficiency.

Catalent’s Bloomington location provides drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

  • Collaborate with and influence a cross-functional support team to deliver the safety, quality, and operational goals of the Drug Substance business unit as the control system owner

  • Maintain the safe and qualified design and operation of the control systems

  • Lead the monitoring, trending, and troubleshooting of routine and novel equipment and operational problems to minimize risks to personnel and product.

  • Investigate and author deviations using formal root cause analysis techniques, their experience, and/or seeking recommendations from industry experts to prevent recurrence of equipment related deviations.

  • Author and drive changes and improvement opportunities (SOP updates, modifications, etc.) through the change management system

  • Identify and implement continuous improvements for equipment maintenance documents for planning and execution to improve safety, improve equipment performance, reduce cost, improve compliance, or reduce operational risks

  • Lead and/or participate in design/user specification development, commissioning, P&ID/GA drawings, automation control strategies, and IQ/OQ/PQ activities of new equipment or changes to existing capabilities

  • Develop operations and technical documents

  • Directly interface with internal customers and operational team members including other engineering technicians, operators, and maintenance personnel

  • Provide internal/external audit support

  • Mentor other engineers and support staff

The Candidate:

  • Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline - Required

  • PE / Registered Engineer - Preferred

  • OSHA 30 /IOSH Managing safely or equivalent a plus, OSHA 10 or equivalent

  • 8+ years of Project Engineering related experience

  • 3+ years in a regulated industry (Life Sciences preferred)

  • Must be able to read and understand English-written job instructions and safety requirements

Additional Information

  • 8-hour days

  • Must be willing to work extended hours during peak periods

  • Must be willing to respond to off-hour emergencies, when necessary.

  • Occasional travel may be required for training, conferences, capital projects

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Delivers Results

  • Leads with Integrity and Respect

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Defined career path and annual performance review & feedback process

  • Potential for career growth and development

  • Cross functional exposure to other areas of Quality and Production

  • Medical, Dental, Vision, and 401 K are all offered from day one of employment

  • 19 days of paid time off annually + 8 paid holidays

  • Onsite Company gym and cafeteria

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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