BioSpace, Inc.
Sr Principal Engineer - Systems MES
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 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.
The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is responsible for the deployment and continuous improvement of the Manufacturing Execution System (MES) at RTP. This role will pair technical mastery of MES for drug product operations with cross-functional collaboration to expand the MES footprint as part of the overall site ramp up, in alignment with RTP business objectives and IT standards.
Responsibilities:
MES Delivery Provide technical leadership to deploy MES Electronic Batch Record (EBR) and associated ancillary electronic tickets to new 7 manufacturing lines in 2025-2026. Provide technical leadership to migrate Electronic Batch Record (EBR) and associated ancillary electronic tickets for existing manufacturing lines from a legacy MES to a modern MES, according to global program timelines. Collaborate with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality, Operations, Learning & Development, and global counterparts to ensure integration of MES with existing site intralogistics system for automated material movement. MES Technical Leadership
Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes. Partner with MES analysts and cross-functional business partners (Supply Chain, Engineering/Process Automation, Quality, Operations) to deliver and monitor outcomes. Own the site MES roadmap, incorporating digital plant initiatives such as wearables, handhelds, advanced analytics, AI, while also and evolving expectations for quality, safety, information security, etc. Provide ongoing communication on projects, issues, and major deliverables to appropriate governance bodies inside and outside the RTP site. Site IT Leadership
Provide input to tactical direction of the RTP IT organization as a member of the RTP IT leadership team. Promote a culture of compliance and advocate for quality improvement practices in EBR design and maintenance. Comply with the safety goals and objectives of the organization and incorporate safety principles into MES design, as applicable. Provide technical coaching to MES analysts and cross-functional MES colleagues, consistent with Lilly values, with emphasis on knowledge management, accountability, and continuous improvement. External Focus
Represent RTP at MES Network Forums and within the Parenteral and Dry Product Network (PDN) to share and apply learnings. Conduct benchmarking and maintain linkage with external forums and bodies. Influence evolution of MES within RTP and Lilly based on external benchmarking. Basic Qualifications/Requirements:
Bachelor's Degree in IT, Engineering or related discipline. 7+ years' experience in IT and/or Engineering Automation/control systems related fields. 5+ years' experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PharmaSuite. Additional Skills/Preferences:
Experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PMX. Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals. Understanding of ISA-95 network infrastructure and internal DMZ Technology experience including Windows OS, Linux OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, ServiceNow. Willing to temporarily work irregular hours, shifts, weekends for facility startup. Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g. cGMP's, FDA 21 CFR Part 11) and other applicable regulations (e.g. privacy, OSHA, etc.). Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus. Strong analytical and problem-solving skills. Highly motivated and self-starter. Experience with manufacturing systems such as warehouse management, automated storage & retrieval, SAP, robotics. Previous experience with Agile or LEAN. Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously. Experience working in a global organization.
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.
The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is responsible for the deployment and continuous improvement of the Manufacturing Execution System (MES) at RTP. This role will pair technical mastery of MES for drug product operations with cross-functional collaboration to expand the MES footprint as part of the overall site ramp up, in alignment with RTP business objectives and IT standards.
Responsibilities:
MES Delivery Provide technical leadership to deploy MES Electronic Batch Record (EBR) and associated ancillary electronic tickets to new 7 manufacturing lines in 2025-2026. Provide technical leadership to migrate Electronic Batch Record (EBR) and associated ancillary electronic tickets for existing manufacturing lines from a legacy MES to a modern MES, according to global program timelines. Collaborate with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality, Operations, Learning & Development, and global counterparts to ensure integration of MES with existing site intralogistics system for automated material movement. MES Technical Leadership
Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes. Partner with MES analysts and cross-functional business partners (Supply Chain, Engineering/Process Automation, Quality, Operations) to deliver and monitor outcomes. Own the site MES roadmap, incorporating digital plant initiatives such as wearables, handhelds, advanced analytics, AI, while also and evolving expectations for quality, safety, information security, etc. Provide ongoing communication on projects, issues, and major deliverables to appropriate governance bodies inside and outside the RTP site. Site IT Leadership
Provide input to tactical direction of the RTP IT organization as a member of the RTP IT leadership team. Promote a culture of compliance and advocate for quality improvement practices in EBR design and maintenance. Comply with the safety goals and objectives of the organization and incorporate safety principles into MES design, as applicable. Provide technical coaching to MES analysts and cross-functional MES colleagues, consistent with Lilly values, with emphasis on knowledge management, accountability, and continuous improvement. External Focus
Represent RTP at MES Network Forums and within the Parenteral and Dry Product Network (PDN) to share and apply learnings. Conduct benchmarking and maintain linkage with external forums and bodies. Influence evolution of MES within RTP and Lilly based on external benchmarking. Basic Qualifications/Requirements:
Bachelor's Degree in IT, Engineering or related discipline. 7+ years' experience in IT and/or Engineering Automation/control systems related fields. 5+ years' experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PharmaSuite. Additional Skills/Preferences:
Experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PMX. Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals. Understanding of ISA-95 network infrastructure and internal DMZ Technology experience including Windows OS, Linux OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, ServiceNow. Willing to temporarily work irregular hours, shifts, weekends for facility startup. Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g. cGMP's, FDA 21 CFR Part 11) and other applicable regulations (e.g. privacy, OSHA, etc.). Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus. Strong analytical and problem-solving skills. Highly motivated and self-starter. Experience with manufacturing systems such as warehouse management, automated storage & retrieval, SAP, robotics. Previous experience with Agile or LEAN. Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously. Experience working in a global organization.
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