JOB DESCRIPTION
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.
MES System Engineer
Position Title: MES System Engineer
Position Type: Full-time
Job Family: Information Technology
Location/s: Alcobendas, Fegersheim, Sesto
Job Function: Tech@Lilly
Tech Ladder (Y/N): Y
Lilly’s Purpose
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 more than 45,000 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 entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site’s and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.
Position Brand Description
We are on an ambitious journey to transform our manufacturing operations, and the Manufacturing Execution System (MES) is pivotal to achieving this transformation. Multiple projects are currently underway to expand the footprint of MES, enabling new facilities to operate paperless and modernizing MES in established operations worldwide.
The MES System Engineer will ensure the successful implementation of the NextGen MES solution by bridging business needs and technology. This role will develop expertise in PharmaSuite, supporting, developing and validating global electronic batch records to fulfill business needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.
Key Responsibilities:
* Develop and integrate MES common and site-specific components.
* Benchmark on innovative solutions (external and internal to Lilly)
* Dynamically adapt roadmap to site evolution/strategic directions, and new trends/issues.
* Establish a strong site culture based in Lilly values, expectations, and operational excellence standards.
* Support MES solutions start up activities.
* Work with site resources towards replication & standardization to drive value and implement the appropriate technical solutions.
* Evaluate emerging technologies and implications to existing Lilly footprint.
* Maintain open communication with MES vendor(s) to address needs in standard solution or via functional packs.
* Evaluate and translate functional requirements into technical solutions.
* Ensure project and/or validation documentation is maintained during lifecycle & release management.
* Develops \ assists in the creation and maintenance of the MES interfaces with other Lilly systems.
What You Should Bring (preferred skills)
* Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
* Effective people and team leadership skills
* Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities.
* Ability to cross functionally collaborate.
* Excellent written and oral communication skills.
* Demonstrate creativity, analytical thinking, and the ability to troubleshoot and solve problems.
* History of promoting safety and maintaining a safe work environment
* Establish a strong site culture based in Lilly values, expectations, and operational excellence standards.
* Demonstrated adhere adherence to compliance for internal and external quality guidance.
* Demonstrated and promote Operational Excellence
* Effectively encourage knowledge sharing and education
* Evaluate and translate functional requirements into technical solutions.
* Ability to problem solving and work through manufacturing situations. Have experience serving as an escalation contact with vendor(s)
* Proven technical ability to develop and integrate MES solutions
Basic Requirements:
* Bachelor’s degree in Engineering, Computer Science, Information Technology, or equivalent years of experience.
* Minimum 2 years of experience working with Manufacturing Execution Systems (MES), preferably in the pharmaceutical or life sciences industry.
* Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
* Experience authoring and validating Master Batch Records (MBRs) in a regulated environment.
* Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
* Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.
* Familiarity with MES platforms such as PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred.
* Proficiency in English (written and spoken).
Additional Information:
* Position locations: Alcobendas, Fegersheim, Sesto
* Occasional off-hours and weekend work expected.
* 10-15% domestic/international travel required.
Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Lilly 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. #WeAreLilly
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 (*******************************************************) 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 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.
#WeAreLilly
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