Engineer Quality Assurance
Company Name:
Elanco
Company Overview
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 1,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Responsibilities
This position will provide quality oversight and support to the Elanco Augusta Technology Centers facilities, utilities, maintenance, and engineering (FUME) with specific focus on the Form/Fill Capacity Expansion Project at the site. The QA Engineer (QAE) will provide quality assistance and guidance to the project team for the design, construction, utilities/HVAC, equipment, commissioning and qualification (C&Q), validations, change controls, procedures, and other activities as needed for the Form/Fill expansion. The QAE will provide daily review and support of the project with presence at team meetings and on the construction site. The QAE is essential for establishing and maintaining GMP compliance as the Form/Fill capacity expansion project is delivered and ensuring the delivered project is prepared for inspections by regulatory agencies. The QAE will also partner with the other site QAEs to help support the API Capacity Expansion Project and to provide oversight with the FUME systems and processes currently utilized by the site.
Key Objectives/Deliverables:
Educate production/project team members on pertinent quality regulations
Influence and oversee the quality of the design, commissioning, and qualification of the facility, equipment, and utilities delivered as part of the project
Ensure regular presence during construction of the new facility to monitor GMP programs and systems
Review, redline, and/or approve GMP documents supporting the project and the existing FUME process at the site (examples: specifications, C&Q documents, change controls, procedures, deviations, and protocols)
Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long term resolutions
Participate in self led and/or regulatory inspections
Provide additional support and back-up to the QAE responsible for the API Expansion Project
Partner with the other site QAEs to provide oversight and improve the existing FUME processes at the site
Basic Qualifications
Bachelors of Science degree (4 year college)- Engineering degree preferred
Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Additional Skills/Preferences
Previous experience in Engineering, Quality for Engineering, or Quality Assurance in pharmaceutical manufacturing
Previous experience supporting a parenteral manufacturing formulation and filling operation
Previous experience supporting the construction of a pharmaceutical manufacturing facility
Previous experience maintaining and/or supporting the FUME Quality System
Strong knowledge of Commissioning and Qualification
Proficiency with computer systems including Microsoft Office products
Demonstrated strong oral and written communication and interpersonal interaction skills
Root cause analysis/troubleshooting skills
Responsible for maintaining a safe work environment and working safely
Strong technical writing and written communication skills
Previous experience with Computer Systems Validation
Proficiency with Trackwise and Regulus computer systems
Demonstrated relevant experience (Quality Assurance, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP
Additional Information
Role will be primarily M-F during normal business hours
Working greater than 40 hours/week may be required
May be required to be on call/present during off hours to support project/production needs
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status
Apply online at:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=11369BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
Elanco
Company Overview
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 1,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Responsibilities
This position will provide quality oversight and support to the Elanco Augusta Technology Centers facilities, utilities, maintenance, and engineering (FUME) with specific focus on the Form/Fill Capacity Expansion Project at the site. The QA Engineer (QAE) will provide quality assistance and guidance to the project team for the design, construction, utilities/HVAC, equipment, commissioning and qualification (C&Q), validations, change controls, procedures, and other activities as needed for the Form/Fill expansion. The QAE will provide daily review and support of the project with presence at team meetings and on the construction site. The QAE is essential for establishing and maintaining GMP compliance as the Form/Fill capacity expansion project is delivered and ensuring the delivered project is prepared for inspections by regulatory agencies. The QAE will also partner with the other site QAEs to help support the API Capacity Expansion Project and to provide oversight with the FUME systems and processes currently utilized by the site.
Key Objectives/Deliverables:
Educate production/project team members on pertinent quality regulations
Influence and oversee the quality of the design, commissioning, and qualification of the facility, equipment, and utilities delivered as part of the project
Ensure regular presence during construction of the new facility to monitor GMP programs and systems
Review, redline, and/or approve GMP documents supporting the project and the existing FUME process at the site (examples: specifications, C&Q documents, change controls, procedures, deviations, and protocols)
Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long term resolutions
Participate in self led and/or regulatory inspections
Provide additional support and back-up to the QAE responsible for the API Expansion Project
Partner with the other site QAEs to provide oversight and improve the existing FUME processes at the site
Basic Qualifications
Bachelors of Science degree (4 year college)- Engineering degree preferred
Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Additional Skills/Preferences
Previous experience in Engineering, Quality for Engineering, or Quality Assurance in pharmaceutical manufacturing
Previous experience supporting a parenteral manufacturing formulation and filling operation
Previous experience supporting the construction of a pharmaceutical manufacturing facility
Previous experience maintaining and/or supporting the FUME Quality System
Strong knowledge of Commissioning and Qualification
Proficiency with computer systems including Microsoft Office products
Demonstrated strong oral and written communication and interpersonal interaction skills
Root cause analysis/troubleshooting skills
Responsible for maintaining a safe work environment and working safely
Strong technical writing and written communication skills
Previous experience with Computer Systems Validation
Proficiency with Trackwise and Regulus computer systems
Demonstrated relevant experience (Quality Assurance, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP
Additional Information
Role will be primarily M-F during normal business hours
Working greater than 40 hours/week may be required
May be required to be on call/present during off hours to support project/production needs
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status
Apply online at:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=11369BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
