Manager, MES

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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long‑term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html