BioSpace, Inc.
QA Engineering - FUME
BioSpace, Inc., Durham, North Carolina, United States, 27703
Job Details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
The QA Engineer supports the site with focus on oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment. The QA Engineer position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
Responsibilities:Act as a FUME SME, working with Global Facilities Delivery, Lilly project staff, Global CSQA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Lilly Global Quality System requirements into the design:Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.Consult with Network and Global quality groups including GQS and Global Quality as required to ensure a consistent and compliant approach is executed during the project and startup phase.Provide technical and quality review and approval of project FUME system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems including review of test cases, test execution, discrepancy resolution, etc.Work with the Site Compliance Manager to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff.Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.Lead project initiatives needed in support of the project and Quality function.Resolve or escalate any compliance issues to the project, site, and Quality Management.Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.Participate in self-led inspections and provide support during internal/external regulatory inspections.Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).Participate in continuous improvement projects to help improve productivity within the local process team or quality organization.Basic Qualifications:
Bachelors degree in engineering, computer science, or another science related field preferred.At least 7 years working in the pharmaceutical QA roles.Previous Pharmaceutical FUME experience.Experience with FUME systems qualification including regulations governing them.Demonstrated strong oral and written communication and interpersonal interaction skillsDemonstrated strong technical writing skills.Additional Preferences:
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Previous facility or area start up experience.Previous experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.Previous experience with Maintenance systems.Six Sigma Green Belt or Lean Training/Experience.CQE certification from the American Society for Quality (ASQ)Additional Information:
Ability to work 8 hour days - Monday through FridayAbility to work overtime as required.Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations and support of site FATs as required.The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.Position may require a short duration assignment of 1-2 months in Indianapolis to establish global contacts.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
The QA Engineer supports the site with focus on oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment. The QA Engineer position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
Responsibilities:Act as a FUME SME, working with Global Facilities Delivery, Lilly project staff, Global CSQA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Lilly Global Quality System requirements into the design:Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.Consult with Network and Global quality groups including GQS and Global Quality as required to ensure a consistent and compliant approach is executed during the project and startup phase.Provide technical and quality review and approval of project FUME system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems including review of test cases, test execution, discrepancy resolution, etc.Work with the Site Compliance Manager to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff.Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.Lead project initiatives needed in support of the project and Quality function.Resolve or escalate any compliance issues to the project, site, and Quality Management.Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.Participate in self-led inspections and provide support during internal/external regulatory inspections.Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).Participate in continuous improvement projects to help improve productivity within the local process team or quality organization.Basic Qualifications:
Bachelors degree in engineering, computer science, or another science related field preferred.At least 7 years working in the pharmaceutical QA roles.Previous Pharmaceutical FUME experience.Experience with FUME systems qualification including regulations governing them.Demonstrated strong oral and written communication and interpersonal interaction skillsDemonstrated strong technical writing skills.Additional Preferences:
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Previous facility or area start up experience.Previous experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.Previous experience with Maintenance systems.Six Sigma Green Belt or Lean Training/Experience.CQE certification from the American Society for Quality (ASQ)Additional Information:
Ability to work 8 hour days - Monday through FridayAbility to work overtime as required.Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations and support of site FATs as required.The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.Position may require a short duration assignment of 1-2 months in Indianapolis to establish global contacts.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly