Manager, MES

AbbVie•Irvine, CA

1d•$109,500 - $208,500•Onsite

About The Position

The primary function is to lead the team of Business Analysts to develop, validate, implement, and troubleshoot the setup of MES (POMs) recipes for the site. Ensure that the site follows Global IT standards in MES while overseeing the integration of other programs with MES such as but not limited to Maximo, SAP, Automation, etc.

Requirements

Bachelors Degree in Business Administration, Engineering or Computer/Information Systems.
Minimum 8 years of experience in manufacturing or quality area 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.

Nice To Haves

Masters Degree preferred.

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.