BioSpace, Inc.
QA Engineer
BioSpace, Inc., Lebanon, Indiana, United States, 46052
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 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.
Company Overview: 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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
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 Description:
The Engineer - QA is responsible for providing technical guidance and leadership to the LP1 site regarding the quality standards employed to maintain and improve site operations. The area of focus includes utilities, bulk distributed materials (BDMs), and facilities/equipment qualification.
Key Objectives/Deliverables:
Provide direct quality oversight of production, engineering, automation, and laboratory operations. Review and approve documents including, but not limited to, procedures, change control proposals, deviations, and equipment/system qualification/validation Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems. Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems. Conduct gap assessments of global requirements and ensure implementation of the governing standards. Participate in and/or lead, support self-inspection activities and regulatory inspections. Maintain and improve FUME quality systems. Assist business partners in the interpretation of regulatory and corporate requirements. Basic Requirements:
BS in Engineering or science-related field GMP manufacturing knowledge and/or experience. 2+ years manufacturing experience Must be mobile to Puerto Rico
Additional Preferences:
Thorough technical understanding of quality systems and regulatory requirements. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Experience in API or finished product manufacturing, QA or Engineering. Experience with system and equipment qualifications. Knowledge of cGMPs and quality systems. Demonstrated strong written and verbal communications skills. Strong attention to detail. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Demonstrated flexibility when faced with changing priorities. Proficiency with computer system applications and process automation systems.
Additional Info:
Strong potential for an immediate assignment to a Lilly Facility in Puerto Rico for an assignment of 6 months-1 year.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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 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.
Company Overview: 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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
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 Description:
The Engineer - QA is responsible for providing technical guidance and leadership to the LP1 site regarding the quality standards employed to maintain and improve site operations. The area of focus includes utilities, bulk distributed materials (BDMs), and facilities/equipment qualification.
Key Objectives/Deliverables:
Provide direct quality oversight of production, engineering, automation, and laboratory operations. Review and approve documents including, but not limited to, procedures, change control proposals, deviations, and equipment/system qualification/validation Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems. Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems. Conduct gap assessments of global requirements and ensure implementation of the governing standards. Participate in and/or lead, support self-inspection activities and regulatory inspections. Maintain and improve FUME quality systems. Assist business partners in the interpretation of regulatory and corporate requirements. Basic Requirements:
BS in Engineering or science-related field GMP manufacturing knowledge and/or experience. 2+ years manufacturing experience Must be mobile to Puerto Rico
Additional Preferences:
Thorough technical understanding of quality systems and regulatory requirements. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Experience in API or finished product manufacturing, QA or Engineering. Experience with system and equipment qualifications. Knowledge of cGMPs and quality systems. Demonstrated strong written and verbal communications skills. Strong attention to detail. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Demonstrated flexibility when faced with changing priorities. Proficiency with computer system applications and process automation systems.
Additional Info:
Strong potential for an immediate assignment to a Lilly Facility in Puerto Rico for an assignment of 6 months-1 year.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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