The Senior Manager Quality Assurance (QA) will lead a team of QA staff and provide QA leadership and QA oversight in support of the Plant Quality Assurance (PQA) team members for AR5. The Senior Manager QA will report to the Director of Quality Assurance for AR5 and as a member of this leadership team will contribute to fostering and further developing the culture of Safety and Quality at ARI. Responsibilities: Staff Management - Maintains the safety of self and others, actively engages with the Amgen Environmental Health, Safety and Sustainability (EHSS) safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program. Quality Oversight and Leadership - Ensures the Quality Management System processes...
Sep 30, 2020
Full time
The Senior Manager Quality Assurance (QA) will lead a team of QA staff and provide QA leadership and QA oversight in support of the Plant Quality Assurance (PQA) team members for AR5. The Senior Manager QA will report to the Director of Quality Assurance for AR5 and as a member of this leadership team will contribute to fostering and further developing the culture of Safety and Quality at ARI. Responsibilities: Staff Management - Maintains the safety of self and others, actively engages with the Amgen Environmental Health, Safety and Sustainability (EHSS) safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program. Quality Oversight and Leadership - Ensures the Quality Management System processes...
Seasonal Full-time Warehouse Team Member - $1000 sign-on bonus Hourly pay rate: Earn $15.25 - $18.25/hr, plus benefits and a $1,000 sign-on bonus. * Limited-Time Opportunity Location: Milford, MA Job opportunities vary by location. We update postings daily with open positions. Shifts: Overnight, Early Morning, Day, Evening, Weekend Seasonal full-time jobs with benefits. Training is provided, no experience necessary. Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Find out what Amazon is doing to provide a safe environment for employees at this time on our COVID-19 FAQ page. Join Amazon and become part of the dedicated team that gets orders ready for people relying on Amazon's service. Earn a competitive wage while learning new skills. Stay active in this fast-paced warehouse environment. In this full-time role, you'll work 8-10 hour shifts for 40 hours per week. Shift...
Sep 30, 2020
Full time
Seasonal Full-time Warehouse Team Member - $1000 sign-on bonus Hourly pay rate: Earn $15.25 - $18.25/hr, plus benefits and a $1,000 sign-on bonus. * Limited-Time Opportunity Location: Milford, MA Job opportunities vary by location. We update postings daily with open positions. Shifts: Overnight, Early Morning, Day, Evening, Weekend Seasonal full-time jobs with benefits. Training is provided, no experience necessary. Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Find out what Amazon is doing to provide a safe environment for employees at this time on our COVID-19 FAQ page. Join Amazon and become part of the dedicated team that gets orders ready for people relying on Amazon's service. Earn a competitive wage while learning new skills. Stay active in this fast-paced warehouse environment. In this full-time role, you'll work 8-10 hour shifts for 40 hours per week. Shift...
Seasonal Full-time Warehouse Team Member - $1000 sign-on bonus Hourly pay rate: Earn $15.25 - $18.25/hr, plus benefits and a $1,000 sign-on bonus. * Limited-Time Opportunity Location: Milford, MA Job opportunities vary by location. We update postings daily with open positions. Shifts: Overnight, Early Morning, Day, Evening, Weekend Seasonal full-time jobs with benefits. Training is provided, no experience necessary. Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Find out what Amazon is doing to provide a safe environment for employees at this time on our COVID-19 FAQ page. Join Amazon and become part of the dedicated team that gets orders ready for people relying on Amazon's service. Earn a competitive wage while learning new skills. Stay active in this fast-paced warehouse environment. In this full-time role, you'll work 8-10 hour shifts for 40 hours per week. Shift...
Sep 30, 2020
Full time
Seasonal Full-time Warehouse Team Member - $1000 sign-on bonus Hourly pay rate: Earn $15.25 - $18.25/hr, plus benefits and a $1,000 sign-on bonus. * Limited-Time Opportunity Location: Milford, MA Job opportunities vary by location. We update postings daily with open positions. Shifts: Overnight, Early Morning, Day, Evening, Weekend Seasonal full-time jobs with benefits. Training is provided, no experience necessary. Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Find out what Amazon is doing to provide a safe environment for employees at this time on our COVID-19 FAQ page. Join Amazon and become part of the dedicated team that gets orders ready for people relying on Amazon's service. Earn a competitive wage while learning new skills. Stay active in this fast-paced warehouse environment. In this full-time role, you'll work 8-10 hour shifts for 40 hours per week. Shift...
The Quality Assurance Specialist will be responsible for On The Floor (primary role) and Off The Floor activities for Quality Assurance 1st Shift (Tuesday through Friday 6am - 4pm). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. The role has the ability to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance Shift 1 provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems responsibilities include the following: Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing. Practices (cGMP), Good Distribution Practices (GDP). Ensures that...
Sep 30, 2020
Full time
The Quality Assurance Specialist will be responsible for On The Floor (primary role) and Off The Floor activities for Quality Assurance 1st Shift (Tuesday through Friday 6am - 4pm). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. The role has the ability to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance Shift 1 provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems responsibilities include the following: Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing. Practices (cGMP), Good Distribution Practices (GDP). Ensures that...
Amgen is a leading human therapeutics' company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. The Information Systems (IS) Engineer plays a meaningful role in building and maintaining strong partnership with the business by ensuring systems reliability, maintenance and lifecycle management! As an IS Engineer in the Information Systems Team, you will work as the technical SME for manufacturing applications, business/laboratory/standalone systems at the site. As a member of a team of engineers and analysts, you will use the business analysis tools, computerized systems knowledge and engineering principles to implement technology solutions to support the business processes in a cGMP environment....
Sep 29, 2020
Full time
Amgen is a leading human therapeutics' company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. The Information Systems (IS) Engineer plays a meaningful role in building and maintaining strong partnership with the business by ensuring systems reliability, maintenance and lifecycle management! As an IS Engineer in the Information Systems Team, you will work as the technical SME for manufacturing applications, business/laboratory/standalone systems at the site. As a member of a team of engineers and analysts, you will use the business analysis tools, computerized systems knowledge and engineering principles to implement technology solutions to support the business processes in a cGMP environment....
The Associate Automation Engineer works with the Manager of the Automation group. The position is responsible for providing Automation Engineering support at the Amgen Rhode Island site. Responsibilities: Work closely with multiple functions, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Provide technical support to commercial and clinical manufacturing as needed, specific to process control, automation infrastructure and utility systems. Fix and resolve equipment, automation or process issues in the field. Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity. Ability to highlight issues and proposing solutions. Work in a small group of engineers and/or technicians on an ongoing or project basis. Execute tasks under the general direction of lead engineers to complete design...
Sep 29, 2020
Full time
The Associate Automation Engineer works with the Manager of the Automation group. The position is responsible for providing Automation Engineering support at the Amgen Rhode Island site. Responsibilities: Work closely with multiple functions, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Provide technical support to commercial and clinical manufacturing as needed, specific to process control, automation infrastructure and utility systems. Fix and resolve equipment, automation or process issues in the field. Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity. Ability to highlight issues and proposing solutions. Work in a small group of engineers and/or technicians on an ongoing or project basis. Execute tasks under the general direction of lead engineers to complete design...
The Senior Validation Engineer position is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions in AR5 and managing the life cycle of ARI's product portfolio. This role will focus on manufacturing validation activities at ARI including but not limited to cleaning validation, SIP/Autoclave validation and analytical equipment validation. Scope of Responsibility Develop the manufacturing validation strategy. Compare/contrast current vs future state based on information provided in detailed design meetings, change controls, etc. in order to assess changes for impact to validation. Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case. Develop area/project specific...
Sep 29, 2020
Full time
The Senior Validation Engineer position is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions in AR5 and managing the life cycle of ARI's product portfolio. This role will focus on manufacturing validation activities at ARI including but not limited to cleaning validation, SIP/Autoclave validation and analytical equipment validation. Scope of Responsibility Develop the manufacturing validation strategy. Compare/contrast current vs future state based on information provided in detailed design meetings, change controls, etc. in order to assess changes for impact to validation. Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case. Develop area/project specific...
D-shift Inoc/Seeds (Night rotation 7PM-7AM) Under minimal supervision, Associate Manufacturing will perform operations in the Inoc/Seeds area per Standard Operating Procedures. Associate will perform and monitor critical processes (i.e., Inoculations, WIP Lab operations, SIP and CIP), execute routine validation protocols, and may draft and revise documents such as Manufacturing Procedures, SOPs, and Deviations/CAPA. Associate will perform basic troubleshooting during routine operations. Additionally, the staff member may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing the Inoc/Seeds Department. Basic Qualifications : Bachelor's degree OR Associate's degree and 4 years of Manufacturing or Operations experience OR High School diploma/GED and 6 years of Manufacturing or Operations experience. Preferred Qualifications : Knowledge of Inoc/Seeds operations Knowledge of WIP lab...
Sep 28, 2020
Full time
D-shift Inoc/Seeds (Night rotation 7PM-7AM) Under minimal supervision, Associate Manufacturing will perform operations in the Inoc/Seeds area per Standard Operating Procedures. Associate will perform and monitor critical processes (i.e., Inoculations, WIP Lab operations, SIP and CIP), execute routine validation protocols, and may draft and revise documents such as Manufacturing Procedures, SOPs, and Deviations/CAPA. Associate will perform basic troubleshooting during routine operations. Additionally, the staff member may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing the Inoc/Seeds Department. Basic Qualifications : Bachelor's degree OR Associate's degree and 4 years of Manufacturing or Operations experience OR High School diploma/GED and 6 years of Manufacturing or Operations experience. Preferred Qualifications : Knowledge of Inoc/Seeds operations Knowledge of WIP lab...
Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? We have a position available for a Senior Engineer to join our Upstream Process Engineering team at our Rhode Island Site. The Sr. Engineer will be part of a team focused on bioprocess optimization, drug substance manufacturing support and new product introductions. The site operates two multi-product facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility. Responsibilities include: Apply a fundamental understanding of mammalian cell culture operations to support commercial manufacturing processes: Scale up of cell culture Single Use...
Sep 23, 2020
Full time
Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? We have a position available for a Senior Engineer to join our Upstream Process Engineering team at our Rhode Island Site. The Sr. Engineer will be part of a team focused on bioprocess optimization, drug substance manufacturing support and new product introductions. The site operates two multi-product facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility. Responsibilities include: Apply a fundamental understanding of mammalian cell culture operations to support commercial manufacturing processes: Scale up of cell culture Single Use...
The Automation Engineer works with the Manager of the Automation group. The position is responsible for providing Automation Engineering support at the Amgen Rhode Island site. Responsibilities include: Work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement automation solutions for manufacturing and site utilities. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and automation infrastructure. Provide technical support to troubleshoot and resolve equipment, automation or process issues in the field. Ensure efficient performance and reliability for process and utility automation systems Develop, coordinate, analyze, and present results for operational issues and engineering projects of medium to large scope and complexity. Communicate proactively with supervisor and support staff,...
Sep 23, 2020
Full time
The Automation Engineer works with the Manager of the Automation group. The position is responsible for providing Automation Engineering support at the Amgen Rhode Island site. Responsibilities include: Work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement automation solutions for manufacturing and site utilities. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and automation infrastructure. Provide technical support to troubleshoot and resolve equipment, automation or process issues in the field. Ensure efficient performance and reliability for process and utility automation systems Develop, coordinate, analyze, and present results for operational issues and engineering projects of medium to large scope and complexity. Communicate proactively with supervisor and support staff,...
Rotating Day Shift (6:45am - 7pm) Under general supervision, Manufacturing Process Technician will perform operations in the Manufacturing Services area on night shift. Operations include Equipment Prep, Dispensing, and Bulk Drug Substance (BDS). Responsible for manufacturing support activities according to Standard Operating Procedures (SOPs). Perform and monitor critical processes, execute routine validation protocols, and review documents such as Manufacturing Procedures and SOPs. Responsibilities also include performing troubleshooting and assist in the review of documentation for assigned functions. Technician will be responsible for performing Washer and Autoclave Operations, Picking and Weigh Dispense Operations, and CIP/SIP of BDS Vessels. Basic Qualifications Associate's degree and 2 years of Manufacturing or Operations experience OR 2 years in a technical school setting with hands-on experience OR High school diploma / GED and 4 years of Manufacturing or...
Sep 16, 2020
Full time
Rotating Day Shift (6:45am - 7pm) Under general supervision, Manufacturing Process Technician will perform operations in the Manufacturing Services area on night shift. Operations include Equipment Prep, Dispensing, and Bulk Drug Substance (BDS). Responsible for manufacturing support activities according to Standard Operating Procedures (SOPs). Perform and monitor critical processes, execute routine validation protocols, and review documents such as Manufacturing Procedures and SOPs. Responsibilities also include performing troubleshooting and assist in the review of documentation for assigned functions. Technician will be responsible for performing Washer and Autoclave Operations, Picking and Weigh Dispense Operations, and CIP/SIP of BDS Vessels. Basic Qualifications Associate's degree and 2 years of Manufacturing or Operations experience OR 2 years in a technical school setting with hands-on experience OR High school diploma / GED and 4 years of Manufacturing or...
