MES Program Lead – Manufacturing IT

AbbVie; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie seeks a seasoned MES leader to pilot team-based development and validation of POMS recipes for site operations, ensuring alignment with global IT standards. The role collaborates with cross-functional stakeholders to gather requirements, oversees recipe authoring, and guides start-up to maintenance phases, including FMEA and SOP development.

Ideal candidates bring 8+ years in pharma manufacturing, MES experience, and strong GMP knowledge, with proven leadership and project management

Qualifications

• Bachelor's degree in Business Administration, Engineering or Computer/Information Systems.
• Minimum 8 years of experience in manufacturing or quality in a pharmaceutical manufacturing plant.
• Minimum of 3 years of hands-on experience with an MES.
• Strong Computer Systems Validation skills.
• Good Project Management skills.
• Excellent verbal and written communication.
• Strong Interpersonal and leadership skills.
• Knowledge of GMP, safety regulations.

Responsibilities

• Establish and advance a high performing team of SMEs by recruiting, training, coaching, and developing people, clearly communicating goals, performance expectations, role responsibilities and performance feedback in alignment with AbbVie's Talent philosophy.
• Own the design of POMS for site operations while leading a team of recipe authors to deliver and ensure adequate support to meet POMS SLA which includes troubleshooting complex system issues and product/process investigation.
• Liaison between business plant stakeholders and global MES team, while leading discussion for requirements gathering on process steps with various stakeholders and develop URS (user requirement specifications).
• Manage recipe authoring for first in class templates. Strategize overall validation approach for POMS during start-up and re-validation/verification approaches at maintenance phase, e.g. NPI change.
• Lead in POMS FMEA creation and revision with global team.
• Develop critical SOPs, e.g. BCP, periodic review of system, incident management.
• Lead in continuous improvement projects related to MES.
• Support data integrity projects and compliance, regulatory and internal audits.
• Support the development and configuration of SAP solutions for the manufacturing recipe process utilizing Process Control Records and Specification documents to ensure accurate system integration with MES system.
• Assure fulfillment of Environmental, Health, and Safety (EHS) requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.

Skills

Verbal communication

Written communication

Leadership

Project management

GMP knowledge

Education

Bachelor's degree in Business Administration, Engineering or Computer/Information Systems

Masters degree preferred

Tools

MES

SAP

Maximo

Job description

AbbVie seeks a seasoned MES leader to pilot team-based development and validation of POMS recipes for site operations, ensuring alignment with global IT standards. The role collaborates with cross-functional stakeholders to gather requirements, oversees recipe authoring, and guides start-up to maintenance phases, including FMEA and SOP development.

Ideal candidates bring 8+ years in pharma manufacturing, MES experience, and strong GMP knowledge, with proven leadership and project management