Position Title: Senior MES Program/Portfolio Manager Work Location: Lexington, MA 02421 Assignment Duration: 6 Months Work Arrangement: Hybrid (3 days per week on site)
Position Summary:
Candidate will act as the Portfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at our organization’s Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs.
Key Responsibilities:
Act as the Portfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at our organization’s Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs.
Qualification & Experience:
3+ years’ experience with MES systems (PAS-X preferred) 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.
5+ years’ experience in digital project and program management in a GMP environment.
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:
Experience with PAS-X MES system.
Experience with Trackwise, Veeva systems (or similar)
Experience with Atlassian’s Confluence and JIRA software.
Knowledge of Automation Systems in GMP manufacturing operations.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $120.00/hr - $126.00/hr.
