<p>Automation Engineer II</p> <p>Position Summary:</p> <p>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.</p> <p>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.</p> <p>Catalent Pharma Solutions is hiring an Automation Engineer II. The Automation Engineer II is expected to assist senior engineering staff in the design and implementation of automation systems for clinical and commercial manufacturing. The candidate provides support in automation engineering, design, and validation. The Automation Engineer II 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.</p> <p>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.</p> <p>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.</p> <p>The Role:</p> <ul> <li>Assists or leads the design, specification, and installation of pharmaceutical manufacturing automation systems. Participates in automation expansion and upgrade projects </li><li>Performs and documents hardware/software modifications to existing systems </li><li>Ensures that all automation designs and technical documentation adhere to GMP standards. Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements </li><li>Prepares standard operating procedures for new and existing control equipment </li><li>Trains users on control system functionality (Programmable Logic Controller, Computer/Control Networks, Control Computers and Instrumentation) </li><li>Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology </li><li>Supports software lifecycle, and electronic records/electronic signature compliance efforts. Supports change controls and technical aspects of control equipment investigations, as applicable </li><li>All other duties as assigned </li></ul> <p>The Candidate:</p> <ul> <li>Bachelor's degree in Engineering required, preferably in Chemical or Electrical Engineering </li><li>Must have at least two years of relevant automation experience </li><li>Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required. Experience with other control systems (Siemens, Schneider, etc.) is preferred </li><li>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 </li><li>Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field </li><li>Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds </li></ul> <p>Why you should join Catalent:</p> <ul> <li>Defined career path and annual performance review and feedback process </li><li>Diverse, inclusive culture </li><li>Positive working environment focusing on continually improving processes to remain innovative </li><li>Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives </li><li>152 Hours + 8 paid holidays </li><li>Several Employee Resource Groups focusing on D&I </li><li>Dynamic, fast-paced work environment </li><li>Community engagement and green initiatives </li><li>Generous 401K match </li><li>Company match on donations to organizations </li><li>Medical, dental and vision benefits effective day one of employment </li><li>Tuition Reimbursement - Let us help you finish your degree or start a new degree! </li><li>WellHub program to promote overall physical wellness </li><li>Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories </li></ul> <p>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.</p> <p>personal initiative. dynamic pace. meaningful work.</p> <p>Visit Catalent Careers to explore career opportunities.</p> <p>Catalent is an Equal Opportunity Employer, including disability and veterans.</p> <p>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.</p> <p>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.</p> <p>Important Security Notice to U.S. Job Seekers:</p> <p>Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.</p> <p>California Job Seekers can find our California Job Applicant Notice HERE.</p>