Manager, MES

AbbVie•Irvine, CA

3d•$109,500 - $208,500

About The Position

The Manager, MES leads a team of Business Analysts in developing, validating, implementing, and troubleshooting MES (POMS) recipes for the site. The role ensures the site follows Global IT standards for MES and oversees the integration of other programs with MES, including Maximo, SAP, and Automation. The manager owns the POMS design for site operations, leads recipe authors, and provides support for complex system issues and product or process investigations. The role also coordinates with plant stakeholders and the global MES team, manages validation and compliance activities, and supports continuous improvement, data integrity, and EHS requirements.

Requirements

Bachelor’s degree in Business Administration, Engineering, or Computer/Information Systems.
At least 8 years of experience in a manufacturing or quality area in a pharmaceutical manufacturing plant.
At least 3 years of hands-on experience with an MES.
Strong computer systems validation skills.
Good project management skills.
Excellent verbal and written communication skills.
Strong interpersonal and leadership skills.
Knowledge of GMP and safety regulations.

Nice To Haves

Master’s degree preferred.

Responsibilities

Recruit, train, coach, and develop a high-performing team of SMEs; communicate goals, performance expectations, role responsibilities, and performance feedback.
Own the design of POMS for site operations and lead recipe authors to deliver support meeting POMS SLAs, including troubleshooting complex system issues and product/process investigations.
Liaise between business plant stakeholders and the global MES team; lead requirements-gathering discussions for process steps and develop user requirement specifications (URS).
Manage recipe authoring for first-in-class templates.
Develop the overall POMS validation approach during start-up and re-validation or verification approaches during maintenance, including new product introduction (NPI) changes.
Lead creation and revision of POMS FMEAs with the global team.
Develop critical SOPs, including business continuity plans, periodic system reviews, and incident management.
Lead continuous improvement projects related to MES.
Support data integrity projects and compliance, regulatory, and internal audits.
Support development and configuration of SAP solutions for manufacturing recipes using Process Control Records and Specification documents to ensure accurate integration with MES.
Ensure fulfillment of Environmental, Health, and Safety (EHS) requirements and compliance obligations; promote continuous improvement and consider EHS aspects during design and change processes.