Manager, MES - Irvine, CA

VetJobs; Irvine (CA); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a seasoned Manufacturing MES Lead to establish and guide a high-performing team of SMEs, owning POMS design for site operations and coordinating with global MES teams.

You will validate processes, develop URS, manage recipe authoring, and drive continuous improvement while ensuring data integrity and regulatory compliance in a GMP environment.

Qualifications

• Bachelor's 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.

Responsibilities

• Establish and advance a high performing team of SMEs by recruiting, training, coaching, and developing people, aligned 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.
• Liaison between business plant stakeholders and global MES team, gathering requirements and developing URS.
• Manage recipe authoring for first in class templates and strategize validation approaches during start-up, maintenance, and NPI changes.
• Lead in POMS FMEA creation and revision with global team.
• Develop critical SOPs, e.g. BCP, periodic system reviews, and incident management.
• Lead continuous improvement projects related to MES and data integrity.
• Support SAP configurations for manufacturing recipe processes and ensure MES integration.

Skills

Project Management

Validation skills

Communication

Leadership

GMP knowledge

Education

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

Masters degree preferred

Tools

MES

POMS

SAP

URS

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

Qualifications

• 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.
• 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.

Minimum Education Required

Bachelors

Job Category

Operations

Job Code

Manufacturing Manufacturing

Affiliate Sponsor

AbbVie

Location

• City: Irvine
• State: California

Pay Range

$109500 - 208500 USD

Salary Range

Not Disclosed