Automation Engineer III

Catalent • Chelsea, MA

108d

About The Position

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring an Automation Engineer III. The Automation Engineer III is expected to lead the design and implementation of automation systems for clinical and commercial manufacturing with minimal support from senior engineering staff. The candidate takes part in ownership of automation engineering, design, and validation. The Automation Engineer III contributes to the design and implementation of new control systems to achieve cost effectiveness and robust manufacturing. This individual provides on-going technical support, including the maintenance, installation, startup, commissioning, testing, and qualification of automation systems. This is a full-time salaried role on 1st shift: Monday-Friday with expected hours of 8am-5pm, although overtime may be required depending on production needs. 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.

Requirements

• Bachelor's degree in Chemical, Electrical or Mechanical Engineering required.
• Must have at least three years of relevant experience.
• Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required.
• Requires knowledge of pharmaceutical process equipment and Clean In Place (CIP) systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols.

Nice To Haves

• Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field.

Responsibilities

• Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems.
• Leads automation portion of expansion and upgrade projects.
• Performs and documents hardware/software modifications to existing systems.
• Ensures that all automation designs and technical documentation adhere to Good Manufacturing Practices (GMP) standards.
• Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements.
• Prepares standard operating procedures for new and existing control equipment.
• Trains users on control system functionality (Programmable Logic Controller, Computer/Control Networks, Control Computers and Instrumentation).
• Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology.
• Supports software lifecycle, and electronic records/electronic signature compliance efforts.
• Supports change controls and technical aspects of control equipment investigations, as applicable.
• All other duties as assigned.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continually improving processes to remain innovative.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• 152 Hours + 8 paid holidays.
• Several Employee Resource Groups focusing on D&I.
• Dynamic, fast-paced work environment.
• Community engagement and green initiatives.
• Generous 401K match.
• Company match on donations to organizations.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree