SAP Application Manager

ClinLab Solutions Group; Billerica (MA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

ClinLab Solutions Group is seeking a Hands-on Manufacturing Lead at our Billerica formulation plant to own and optimize drug product manufacturing operations while supporting the SAP S/4HANA rollout. This role bridges Operations and Digital Transformation, ensuring shop-floor adoption and sustained routine operations.

The ideal candidate has SAP experience in manufacturing, GMP knowledge, and 5+ years in pharma/medical device manufacturing with cross-functional collaboration across Quality,

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, or Industrial Engineering.
• Strong GMP and regulatory understanding.
• 5+ years in Pharma/Medical Device manufacturing or relevant experience.

Responsabilités

• Lead design and optimization of manufacturing processes in consultation with global process owners.
• Translate operational requirements into SAP S/4HANA configuration with Digital/IT.
• Validate master data from GMP and operations perspectives.

Connaissances

Bridge operations & digital

GMP knowledge

Problem solving

Formation

Bachelor’s in Pharmacy

BSc in Chemical/Industrial Engineering

Outils

SAP S/4HANA

SAP PP/PI

QM

Production Planning

Description du poste

We are specifically looking for candidates who can serve as a bridge between Manufacturing Operations and Digital Transformation initiatives. The strongest candidates will have: SAP S/4HANA experience within manufacturing environments SAP PP, PP/PI, QM, or Production Planning expertise Experience supporting SAP implementations, upgrades, migrations, or transformation initiatives Experience with UAT, testing, go-live, cutover, hypercare, or process design activities Production Planning, MRP, Process Orders, Production Orders, BOMs, Routings, and Master Data experience Experience partnering with Manufacturing, Quality, Supply Chain, Engineering, and IT teams GMP/GxP regulated manufacturing experience preferred MES, EBR, or LIMS integration experience is a plus, but SAP expertise is the primary focus

Hands-on Manufacturing Lead to own and optimize drug product manufacturing operations at our Billerica formulation plant, while supporting the SAP S/4HANA rollout. This role bridges Operations and Digital Transformation, ensuring that manufacturing processes drive system design, adopted by the shop floor, and sustained in routine operations.

Area Of Responsibility

Process Design & Operational Enablement

• Lead design, mapping, and optimization of manufacturing processes in consultation with global process owners
• Work with Digital/IT to translate operational requirements into SAP S/4HANA configuration
• Validate master data from an operations and GMP perspective
• Ensure GMP/GxP and data integrity compliance in daily manufacturing execution

Implementation & Testing

• Lead FIT–GAP, testing, UAT to ensure operational readiness and continuity of manufacturing execution and integration validation

Go-Live & Adoption

• Train operators, update SOPs, support hypercare to ensure stable and compliant manufacturing operations
• Track KPIs (safety, quality, delivery, cost), and drive continuous improvement initiatives.

Cross-Functional Collaboration

• Liaise with Quality, Supply Chain, Engineering, IT to support effective manufacturing operations
• Liaise with the central operations team for alignment of the process with SUN global template and site operational needs
• Strong shop-floor engagement and ownership of day-to-day operational challenges
• Problem-solving mindset in a regulated manufacturing environment

Other Duties as assigned

Work Conditions:

• Office
• Controlled/manufacturing area

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk and hear
• Be able to multitask
• Operate computer/office machines

20% of time in the initial phase

Education and Job Qualification

Required Qualifications:

• - Bachelor’s in Pharmacy, Chemical Engineering, Industrial Engineering
• - Strong GMP and regulatory understanding
• - 5+ years in Pharma / Medical Device manufacturing or relevant experience

Preferred Qualifications

• - Regulatory exposure

Experience

• Experience with MES/EBR/LIMS as part of manufacturing operations