Role name: MES Business Engineer / Technical BA
Work Location: Albany, New York (Onsite)
Start date: Immediate availability.
Interview Mode: Phone/Video
Type: Contract (C2C/W2)
We are seeking an experienced MES Business Engineer / Technical Business Analyst who can effectively bridge Manufacturing Operations, Business Processes, and Technology teams. This is not a traditional requirements-gathering BA role. The ideal candidate will combine deep manufacturing and MES expertise with strong business process improvement, change management, and technical analysis capabilities.
Key Responsibilities:
- Partner with Manufacturing, Quality, Supply Chain, and IT stakeholders to drive MES-enabled business transformation.
- Analyze and optimize manufacturing processes using Lean principles and continuous improvement methodologies.
- Lead requirements discovery, solution design discussions, and process harmonization for large-scale MES initiatives.
- Support Review-by-Exception (RBE) strategies, electronic batch records, and digital manufacturing workflows.
- Act as the bridge between business users and technical teams, translating operational needs into scalable MES solutions.
- Drive change management, stakeholder engagement, and user adoption across manufacturing sites.
- Support implementation, testing, deployment, and ongoing enhancement of MES capabilities.
Required Skills & Experience
- 8+ years of experience in Manufacturing, MES, Digital Manufacturing, or Technical Business Analysis roles.
- Strong experience with MES platforms (POMS, PAS-X, PharmaSuite, Opcenter, Syncade, or similar).
- Proven experience in large-scale manufacturing system implementations and global transformation programs.
- Strong understanding of GMP-regulated pharmaceutical or biotechnology manufacturing environments.
- Experience with Review-by-Exception, Electronic Batch Records (EBR), manufacturing execution processes, and shop-floor operations.
- Knowledge of Lean Manufacturing, process optimization, and continuous improvement methodologies.
- Ability to engage with both business leadership and technical delivery teams.
- Strong analytical, communication, and stakeholder management skills.
Role name: MES Project Manager
Work Location: Albany, New York (Onsite)
Start date: Immediate availability.
Interview Mode: Phone/Video
Type: Contract (C2C/W2)
We are seeking an experienced MES Project Manager to lead Manufacturing Execution System (MES) initiatives across digital manufacturing programs. The ideal candidate will bring a strong MES background, combining technical expertise with project leadership capabilities to successfully drive MES deployments, enhancements, and business transformation initiatives in a GMP-regulated environment.
Key Responsibilities:
- Lead end-to-end MES projects, ensuring delivery of scope, schedule, budget, and quality objectives.
- Manage cross-functional teams including Manufacturing, Quality, Validation, Automation, IT, and external vendors.
- Drive project planning, risk management, stakeholder communication, and governance activities.
- Provide technical leadership and oversight for MES implementation, integration, and enhancement initiatives.
- Coordinate requirements, solution design, testing, deployment, and hypercare activities.
- Support digital manufacturing transformation programs and continuous improvement initiatives.
- Ensure compliance with GMP, GxP, Data Integrity, and validation requirements.
- Manage project reporting, status updates, issue resolution, and executive stakeholder communications.
Required Skills & Experience:
- 5–7 years of hands-on MES experience in pharmaceutical, biotechnology, or life sciences manufacturing environments.
- Proven experience leading MES implementation or upgrade projects.
- Strong understanding of MES platforms such as POMS, PAS-X, PharmaSuite, Opcenter, or Syncade.
- Demonstrated technical and project leadership capabilities.
- Experience working with Electronic Batch Records (EBR), manufacturing workflows, and shop-floor systems.
- Knowledge of MES integrations with ERP, LIMS, Automation, SCADA, and related manufacturing systems.
- Strong stakeholder management, communication, and problem-solving skills.
- Experience working within regulated environments and managing system validation activities.