Senior MES Program Manager

Virtual Company; Lexington (MA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

The Fountain Group is seeking a Portfolio/Program Manager to lead multiple MES projects at MA Bio Ops. You will track milestones, Change Controls, and CAPAs, and collaborate with cross-functional teams in a GMP setting.

Ideal candidates bring 5+ years in digital project management, 3+ years MES experience, ISA-95/ISA-88 knowledge, and proven vendor coordination skills in a matrixed organization.

Qualifications

• 5+ years in digital project and program management in a GMP environment.
• 3+ years MES systems experience and interfaces (ERP, Automation, Lab).
• Direct experience with Biologics manufacturing processes and equipment.
• ISA-95 and ISA-88 knowledge.
• Experienced with Agile and Waterfall methodologies.
• Ability to work independently in a matrixed environment and influence teams.
• Comfortable working with external vendors.
• Able to lead meetings, identify risks, and manage dependencies across projects.

Responsabilités

• Act as Portfolio/Program Manager for concurrent MES projects.
• Track milestones, Change Controls, and CAPAs.
• Coordinate across GMP manufacturing operations.
• Identify project risks and cross-project dependencies.
• Lead stakeholder meetings and vendor coordination.

Connaissances

Digital project management

Program management

GMP environment experience

Risk management

Vendor management

Meeting facilitation

Cross-functional collaboration

Independent work

Leadership

ISA-95/ISA-88 knowledge

Formation

No degree specified

Outils

TrackWise

Veeva

Confluence

JIRA

Automation systems

Description du poste

Candidate will act as the Portfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at MA Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs.

Required Qualifications:

• 5+ years’ experience in digital project and program management in a GMP environment.
• 3+ years’ experience with MES systems as well as relevant interfaces (ERP, Automation, Lab Systems).
• Direct experience with Biologics manufacturing processes and equipment.
• Understand the ISA-95 and ISA-88 models.
• Experienced with common project management methodologies including Agile and Waterfall.
• Expected to be able to work independently, take initiative, and navigate complex matrixed environment to influence individuals and teams across the organization.
• Comfortable working with external vendors, where applicable.
• Able to lead meetings, identify projects risks, and understand cross project dependencies.

Preferred Qualifications:

• Experience with Trackwise, Veeva systems (or similar).
• Experience with Atlassian’s Confluence and JIRA software.
• Knowledge of Automation Systems in GMP manufacturing operations.

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