Catalent
Overview
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 supports pharma, biotech, and consumer health customers with product development, launch, and full life-cycle supply, powered by thousands of scientists and technicians across more than 40 global sites. 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 on-site spray dryers and multiple commercial-scale lines for capsule filling and blister packaging. The Role
Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems. Leads automation portions of expansion and upgrade projects. Performs and documents hardware/software modifications to existing systems. Ensures automation designs and documentation adhere to GMP standards. Performs 21 CFR Part 11 assessments and GMP evaluations of control systems to ensure FDA compliance. Prepares SOPs for new and existing control equipment. Trains users on control system functionality (PLC, control networks, control computers and instrumentation). Troubleshoots and diagnoses control system problems in collaboration 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. The Candidate
Bachelor’s degree in Chemical, Electrical or Mechanical Engineering required. At least three years of relevant experience. Experience with Rockwell/Allen-Bradley batch control systems required; experience with other control systems (Siemens, Schneider, etc.) preferred. Knowledge of pharmaceutical process equipment and CIP systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols. Preferred experience in FDA-regulated pharmaceutical/biotech operations. Physical requirements: ability to sit, stand, walk regularly and occasionally lift 0-40 pounds. Why you should join Catalent
Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focused on process improvement and innovation Potential for career growth within an expanding team Competitive benefits: Medical, dental, vision; 401K match; tuition reimbursement; wellness programs On-site programs and employee resource groups focusing on D&I Generous paid time off and holiday benefits On-going learning and development opportunities Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email DisabilityAccommodations@catalent.com with job number, title, and location. Notice to Agency and Search Firm Representatives: Catalent does not accept unsolicited resumes for this job posting. Resumes submitted by third-party agencies without a signed search agreement will be the property of Catalent and no fee will be paid. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates for payment or highly sensitive information during the offer process. If you receive such requests, forward to spam@catalent.com for investigation. California Job Seekers can find our California Job Applicant Notice HERE.
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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 supports pharma, biotech, and consumer health customers with product development, launch, and full life-cycle supply, powered by thousands of scientists and technicians across more than 40 global sites. 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 on-site spray dryers and multiple commercial-scale lines for capsule filling and blister packaging. The Role
Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems. Leads automation portions of expansion and upgrade projects. Performs and documents hardware/software modifications to existing systems. Ensures automation designs and documentation adhere to GMP standards. Performs 21 CFR Part 11 assessments and GMP evaluations of control systems to ensure FDA compliance. Prepares SOPs for new and existing control equipment. Trains users on control system functionality (PLC, control networks, control computers and instrumentation). Troubleshoots and diagnoses control system problems in collaboration 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. The Candidate
Bachelor’s degree in Chemical, Electrical or Mechanical Engineering required. At least three years of relevant experience. Experience with Rockwell/Allen-Bradley batch control systems required; experience with other control systems (Siemens, Schneider, etc.) preferred. Knowledge of pharmaceutical process equipment and CIP systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols. Preferred experience in FDA-regulated pharmaceutical/biotech operations. Physical requirements: ability to sit, stand, walk regularly and occasionally lift 0-40 pounds. Why you should join Catalent
Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focused on process improvement and innovation Potential for career growth within an expanding team Competitive benefits: Medical, dental, vision; 401K match; tuition reimbursement; wellness programs On-site programs and employee resource groups focusing on D&I Generous paid time off and holiday benefits On-going learning and development opportunities Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email DisabilityAccommodations@catalent.com with job number, title, and location. Notice to Agency and Search Firm Representatives: Catalent does not accept unsolicited resumes for this job posting. Resumes submitted by third-party agencies without a signed search agreement will be the property of Catalent and no fee will be paid. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates for payment or highly sensitive information during the offer process. If you receive such requests, forward to spam@catalent.com for investigation. California Job Seekers can find our California Job Applicant Notice HERE.
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