MES Recipe Author

AbbVie Inc.; Worcester (MA); In loco; USD 66.000 - 126.000; Tempo pieno

Descrizione del lavoro

AbbVie is seeking a results-driven MES Recipe Author to develop, validate, and maintain electronic batch records within the MES platform (POMSnet Aquila) and support change control in GMP environments. You will work within the Digital Systems organization to ensure data integrity and compliant manufacturing documentation.

The role involves configuring MBRs/EBRs, integrating MES with ERP/LIMS, and translating paper records into digital formats.

Competenze

• Bachelor's degree in Engineering, Computer Science, or related discipline with 2+ years of relevant experience.
• Experience in MES recipe authoring or GMP-regulated manufacturing IT applications.
• Familiarity with MES platforms and ISA-88/ISA-95 standards.
• Understanding of data integrity principles and pharmaceutical regulations.

Mansioni

• Author, configure, and verify master batch records and electronic batch records using MES platforms.
• Support system integration between MES and ERP/LIMS/automation through cross-functional teamwork.
• Translate manufacturing requirements into digital formats and maintain system documentation.
• Perform testing of new MES recipes and system changes.
• Troubleshoot MES issues and provide on-trial support during production.
• Support change management and continuous improvement initiatives.
• Follow EH&S procedures and participate in incident investigations as required.
• Build rapport with colleagues across MES team and business users.

Conoscenze

MES recipe authoring

GMP compliance

Data integrity

IS A-88/ISA-95 knowledge

Formazione

Bachelor's degree in Engineering, Computer Science, or related discipline

Strumenti

POMSnet Aquila

PharmaSuite

Syncade

Werum PAS-X

Descrizione del lavoro

• Compensation: USD 65,500 - USD 125,500 - yearly

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

Seeking a results-driven and technically oriented MES Recipe Author within our pharmaceutical operation, reporting into the Digital Systems organization. The MES Recipe Author plays an important role in developing, validating, and maintaining electronic batch records and recipes within MES platform, POMSnet. This position is responsible for authoring recipes and supporting change control activities in alignment with quality standards and GMP regulations.

Responsibilities:

• Author, configure, and verify master batch records (MBRs), templates, and electronic batch records (EBRs) using MES platforms (e.g., POMSnet Aquila).
• Support system integration activities, helping ensure seamless data flow and interoperability between MES and other enterprise systems (such as ERP, LIMS, automation, and data management platforms) through cross-functional teamwork.
• Analyze manufacturing requirements, collaborate with stakeholders (process engineers, business teams), and translate paper records into digital formats.
• Prioritize and execute support activities to align with project schedules and business needs.
• Author and maintain system and verification documentation, ensuring adherence to GMP, Global, and internal quality standards.
• Demonstrate a high level of integrity and recognize the importance of quality control in pharmaceutical production.
• Perform comprehensive testing of new MES recipes and system changes.
• Troubleshoot MES issues, provide technical support during recipe execution, and resolve incidents in live production.
• Support change management and continuous improvement initiatives contributing to standardization and efficiency.
• Follow Environmental Health and Safety procedures and participate in incident investigations as required.
• Build rapport and communicate effectively with colleagues across and outside the MES team.
• Support business users, ensuring their requirements are understood and delivered at or above expectations.
• The role will evolve to require Off Hours Support for MES systems.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related discipline with a minimum of (two) 2 years of relevant experience.
• Experience in MES recipe authoring or supporting IT applications in GMP-regulated manufacturing (pharma, biotech, medical devices).
• Familiarity with MES solutions (POMSnet Aquila, PharmaSuite, Syncade, Werum PAS-X, or similar), and a working understanding of ISA-88/ISA-95 standards.
• Working understanding of manufacturing processes, pharmaceutical/biopharma regulations, and data integrity principles.
• Experience supporting the authoring of requirements, specifications, and validation/verification protocols.
• Ability to manage multiple tasks, support results-driven work, and collaborate effectively across diverse functions.
• Good troubleshooting, communication, documentation, and organizational skills.
• Detail-oriented, proactive, and self-motivated work ethic.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.