Catalent Pharma Solutions
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 product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing. Catalent operates across more than 40 global sites and supplies billions of doses of life-enhancing and life-saving treatments 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, including on-site spray dryers such as GEA Niro SD1, SD4, and SD7, with SD7 being the largest CGMP unit of its kind for DPI in North America. 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 participates in ownership of automation engineering, design, and validation, and contributes to the design and implementation of new control systems to achieve cost effectiveness and robust manufacturing. This role provides ongoing technical support, including 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. The Role
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 Part 11 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 The Candidate
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. Experience with other control systems (Siemens, Schneider, etc.) is preferred 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 Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field Physical requirements: Individual may be required 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 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. Visit Catalent Careers to explore career 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, 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 and 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.
#J-18808-Ljbffr
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 product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing. Catalent operates across more than 40 global sites and supplies billions of doses of life-enhancing and life-saving treatments 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, including on-site spray dryers such as GEA Niro SD1, SD4, and SD7, with SD7 being the largest CGMP unit of its kind for DPI in North America. 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 participates in ownership of automation engineering, design, and validation, and contributes to the design and implementation of new control systems to achieve cost effectiveness and robust manufacturing. This role provides ongoing technical support, including 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. The Role
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 Part 11 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 The Candidate
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. Experience with other control systems (Siemens, Schneider, etc.) is preferred 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 Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field Physical requirements: Individual may be required 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 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. Visit Catalent Careers to explore career 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, 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 and 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.
#J-18808-Ljbffr