Automation Engineer III

Catalent•Chelsea, MA

2d•$100,000 - $130,000•Onsite

About The Position

Automation Engineer III Position Summary: Work Schedule: Monday – Friday from 8am-5pm, overtime as needed depending on production 100% on-site (Chelsea, MA) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and 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 who 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 ownership of automation engineering, design, validation, and the 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.

Requirements

Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering required
Must have at least three (3) years of relevant experience (defined below)
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
Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds

Nice To Haves

Experience with other control systems (Siemens, Schneider, etc.) is preferred
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
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. personal initiative. dynamic pace. meaningful work.