National Guard Employment Network
Senior Engineer, Quality - Indianapolis, IN Job at National Guard Employment Net
National Guard Employment Network, Indianapolis, IN, United States, 46262
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Sr. Quality Engineer will work cross-functionally to develop and implement engineering solutions that enhance compliance and reliability. This position will be responsible for providing quality oversight on the execution and update of the Validation Master Plan and site metrics. This position provides guidance on CAPA plans and use statistical tools to identify trends and promote continuous improvement. The Sr. Quality Engineer will be responsible for leading root cause analysis efforts using risk management principles. Supporting a Multi-phase to commercial facility. This position reports directly to the Associate Director, of Quality, Indianapolis.
*This is an onsite position located at Rayzebio's Indianapolis, IN site*
Job Responsibilities:
Provide quality support and oversight of equipment validation, computer systems validation, and change management.
Provide quality review and support for the calibration and preventive maintenance programs.
Lead continuous improvement initiatives through cross-functional support and project management techniques.
Participate with the Facilities, Engineering and MS&T teams on new installations/systems and innovation.
Leads cross-functional efforts for process improvement projects through use of statistical tools and various risk analysis tools.
Apply current industry standards and regulations to ensure procedures and policies are compliant with FDA, EU and ISPE GAMP-5 guidelines.
Support the enrollment and approval of assets in the asset management system.
Additional Qualifications/Responsibilities
Education and Experience:
BS/MS in Science related discipline preferred with 5-6+ years of quality assurance or quality engineering experience
Experience working in a GMP aseptic manufacturing environment preferred
Experience working with FDA and EU regulations.
ASQ or ISO certification and previous auditing experience a plus
Skills and Qualifications:
Highly motivated and organized professional with the ability to work independently
Working knowledge of 21 CFR Parts 11, 210, 211 and EU annex
Very personable with strong communication skills
Ability to read and interpret technical documents
Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Sr. Quality Engineer will work cross-functionally to develop and implement engineering solutions that enhance compliance and reliability. This position will be responsible for providing quality oversight on the execution and update of the Validation Master Plan and site metrics. This position provides guidance on CAPA plans and use statistical tools to identify trends and promote continuous improvement. The Sr. Quality Engineer will be responsible for leading root cause analysis efforts using risk management principles. Supporting a Multi-phase to commercial facility. This position reports directly to the Associate Director, of Quality, Indianapolis.
*This is an onsite position located at Rayzebio's Indianapolis, IN site*
Job Responsibilities:
Provide quality support and oversight of equipment validation, computer systems validation, and change management.
Provide quality review and support for the calibration and preventive maintenance programs.
Lead continuous improvement initiatives through cross-functional support and project management techniques.
Participate with the Facilities, Engineering and MS&T teams on new installations/systems and innovation.
Leads cross-functional efforts for process improvement projects through use of statistical tools and various risk analysis tools.
Apply current industry standards and regulations to ensure procedures and policies are compliant with FDA, EU and ISPE GAMP-5 guidelines.
Support the enrollment and approval of assets in the asset management system.
Additional Qualifications/Responsibilities
Education and Experience:
BS/MS in Science related discipline preferred with 5-6+ years of quality assurance or quality engineering experience
Experience working in a GMP aseptic manufacturing environment preferred
Experience working with FDA and EU regulations.
ASQ or ISO certification and previous auditing experience a plus
Skills and Qualifications:
Highly motivated and organized professional with the ability to work independently
Working knowledge of 21 CFR Parts 11, 210, 211 and EU annex
Very personable with strong communication skills
Ability to read and interpret technical documents
Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.