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.

Bachelors Degree in Business Administration, Engineering or Computer/Information Systems. Masters Degree preferred.

Minimum 8 years of experience in manufacturing or quality area in a pharmaceutical manufacturing plant.

Manager, MES

Responsibilities

Qualification

Required

Preferred

Benefits

Company

AbbVie

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