Project Manager, Engineering and Data Integrity

About the role

Entourage, a life sciences consulting firm, is looking for a Project Manager to lead two critical projects for a production plant: redesigning a production department to take on a new product, and rolling out a Data Integrity remediation project for the plant's equipment and systems. The consultant works with internal and external stakeholders and keeps both projects on schedule while planning activities around the site's normal production routine.

Key responsibilities

• Manage two critical projects from start to finish, coordinating engineering, QA, QC, production, IT/OT, plant management and external parties
• Plan project activities around the site's production routine, planned shutdowns and maintenance windows
• Run risk assessments (FMEA, ICH Q9) and set priorities for remediation actions
• Track costs, variances and CAPEX, and write progress reports and track project KPIs
• Coordinate equipment vendors, system integrators and external contractors

Required profile

• Degree in Chemical, Mechanical, Electrical or Automation Engineering, or a similar field
• 3 to 5 years of experience as a project manager in pharmaceutical or other GMP-regulated manufacturing
• Hands-on experience with Data Integrity remediation projects
• PMP, PRINCE2 or IPMA certification preferred
• Fluent English; native Italian speaker

Required skills

• Project management and planning/scheduling in MS Project or Primavera P6
• GMP (EU GMP, FDA cGMP), change control, deviations and CAPA
• Commissioning and qualification (URS, FAT/SAT, IQ/OQ/PQ) and process validation
• Data Integrity (ALCOA+, 21 CFR Part 11, EU GMP Annex 11) and CSV/CSA under GAMP 5
• Risk management (FMEA, ICH Q9) and supplier management
• Advanced Excel and Power BI