Catalent
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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 accelerates development programs and launches 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. The Role
Catalent Pharma Solutions is hiring a Facility Maintenance Engineer. The Facilities Engineer is responsible for the maintenance activities (preventive and corrective) and troubleshooting of Heating, Ventilation, Air Conditioning (HVAC) systems, Good Manufacturing Practices (GMP) utilities, and general plant utilities. This individual provides technical expertise in design, operation, maintenance, and optimization of all plant utility systems. The Plant/Facilities Engineer works closely with the Facilities, Metrology, Computerized Maintenance Management System (CMMS) and Engineering staff to improve the utility system’s performance and reliability. Plan, coordinate, and execute engineering analysis related to pharmaceutical plant operations and process/equipment optimizations. Develop strategy and processes to support 24X7 operations, including troubleshooting and optimization of equipment operational issues, preventive maintenance and system upgrades Interface with stakeholders, vendors, and contractors to align designs and current operations with technical requirements and operational schedules Provide expertise in plant utilities and facilities (e.g., HVAC, USP Water, CIP systems, Autoclaves) and process equipment Lead the design and layout of plant systems, utilities, and manufacturing areas (e.g., cleanrooms, process suites, utilities and solvent storage and handling) Develop, update and review engineering drawings (P&IDs, equipment layouts, etc.) and engineering project life cycle documentation Ensure compliance with GMP, FDA, OSHA, and other applicable regulatory standards. Act as a liaison between the Facilities & Engineering team, manufacturing operations, and quality departments Serve as subject matter expert (SME) in the areas of plant utilities, facilities, engineering and manufacturing equipment. Lead identification, root cause and resolution issues, including all aspects of deviation investigations, change control, and CAPAs All other duties as assigned The Candidate
Requires a Bachelor’s Degree in Mechanical, Chemical, Engineering Technology, or related field Highly preferred to have professional experience in engineering, facilities or operations Two (2) years of GMP-related industry experience is highly preferred Requires relevant work experience in Utilities Systems, Facilities equipment, Building Management/Control Systems (BMS), design, build and operational support Requires direct experience with HVAC units, cooling towers, chilled water centrifugal chillers, process chillers, pure steam and USP water systems Must have strong attention to technical details including engineering life cycle principles, with strong mechanical, instrumentation, electrical and process hands on capabilities. Technical writing skills are required Physical Requirements: Individual may be required stand, walk, sit, reach with hands and arms, climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 40 pounds; minimal travel on a rare basis; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents 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 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. 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. Seniority level
Entry level Employment type
Full-time Job function
Management and Manufacturing Industries
Biotechnology Research and Pharmaceutical Manufacturing If you would like to set job alerts for similar roles, sign in and customize your preferences.
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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 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 accelerates development programs and launches 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. The Role
Catalent Pharma Solutions is hiring a Facility Maintenance Engineer. The Facilities Engineer is responsible for the maintenance activities (preventive and corrective) and troubleshooting of Heating, Ventilation, Air Conditioning (HVAC) systems, Good Manufacturing Practices (GMP) utilities, and general plant utilities. This individual provides technical expertise in design, operation, maintenance, and optimization of all plant utility systems. The Plant/Facilities Engineer works closely with the Facilities, Metrology, Computerized Maintenance Management System (CMMS) and Engineering staff to improve the utility system’s performance and reliability. Plan, coordinate, and execute engineering analysis related to pharmaceutical plant operations and process/equipment optimizations. Develop strategy and processes to support 24X7 operations, including troubleshooting and optimization of equipment operational issues, preventive maintenance and system upgrades Interface with stakeholders, vendors, and contractors to align designs and current operations with technical requirements and operational schedules Provide expertise in plant utilities and facilities (e.g., HVAC, USP Water, CIP systems, Autoclaves) and process equipment Lead the design and layout of plant systems, utilities, and manufacturing areas (e.g., cleanrooms, process suites, utilities and solvent storage and handling) Develop, update and review engineering drawings (P&IDs, equipment layouts, etc.) and engineering project life cycle documentation Ensure compliance with GMP, FDA, OSHA, and other applicable regulatory standards. Act as a liaison between the Facilities & Engineering team, manufacturing operations, and quality departments Serve as subject matter expert (SME) in the areas of plant utilities, facilities, engineering and manufacturing equipment. Lead identification, root cause and resolution issues, including all aspects of deviation investigations, change control, and CAPAs All other duties as assigned The Candidate
Requires a Bachelor’s Degree in Mechanical, Chemical, Engineering Technology, or related field Highly preferred to have professional experience in engineering, facilities or operations Two (2) years of GMP-related industry experience is highly preferred Requires relevant work experience in Utilities Systems, Facilities equipment, Building Management/Control Systems (BMS), design, build and operational support Requires direct experience with HVAC units, cooling towers, chilled water centrifugal chillers, process chillers, pure steam and USP water systems Must have strong attention to technical details including engineering life cycle principles, with strong mechanical, instrumentation, electrical and process hands on capabilities. Technical writing skills are required Physical Requirements: Individual may be required stand, walk, sit, reach with hands and arms, climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 40 pounds; minimal travel on a rare basis; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents 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 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. 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. Seniority level
Entry level Employment type
Full-time Job function
Management and Manufacturing Industries
Biotechnology Research and Pharmaceutical Manufacturing If you would like to set job alerts for similar roles, sign in and customize your preferences.
#J-18808-Ljbffr