At Entourage, we believe work has more value when it respects people, company goals and individual aspirations. We see these three as one starting point for every project, every collaboration and every decision. We are a life sciences consulting firm built around people: the people on our team and the clients we support every day. Five values shape how we work: integrity, openness, ownership, excellence and collaboration. We don't just fill positions. We look for professionals to build something with, in an environment where the quality of work and the quality of life go together. We are convinced that a better working experience, inside and outside the company, is how we make a real difference.

• You manage two critical projects for a production plant: changing a production department so it can take on a new product, and rolling out a Data Integrity remediation project for the plant's equipment and systems.
• You work with internal and external stakeholders and keep both projects on schedule.
• You plan project activities around the site's normal production routine.

Hard skills

• Project management: runs several critical projects at once from start to finish.
• Planning and scheduling: builds and tracks detailed schedules (critical path, CPM) in MS Project or Primavera P6, and fits project activities around production plans, planned shutdowns and maintenance windows.
• New product introduction / technology transfer: changes production departments to take on new products (layout, equipment, utilities, process changes).
• GMP and change control: works in a GMP-regulated environment (EU GMP, FDA cGMP) and manages change control, deviations and CAPA.
• Commissioning and qualification: plans and oversees equipment and facility qualification (URS, FAT/SAT, IQ/OQ/PQ) and process validation.
• Data Integrity: knows ALCOA+ principles, MHRA/FDA/PIC/S Data Integrity guidance, 21 CFR Part 11 and EU GMP Annex 11.
• Computerised systems: knows computerised system validation (CSV/CSA) under GAMP 5, including audit trails, user access management, backup and restore, and data review; has experience with gap assessments and remediation plans for equipment and systems (PLC/SCADA, standalone lab/production equipment, MES/LIMS).
• Risk management: runs risk assessments (FMEA, ICH Q9) and sets priorities for remediation actions.
• Budget and cost control: tracks costs, variances and CAPEX.
• Supplier management: coordinates equipment vendors, system integrators and external contractors.
• Reporting: writes progress reports and tracks project KPIs; advanced Excel and Power BI.
• Native Italian speaker.

Soft skills

• Stakeholder management: works with Engineering, QA, QC, Production, IT/OT, Plant Management, EHS and external parties.
• Communication: raises issues on the critical path clearly and early, and escalates them when needed.
• Negotiation: finds a balance between project needs and production continuity.
• Problem solving and decision-making: solves problems under pressure and against tight deadlines.
• Leadership without formal authority: leads teams drawn from different departments.
• Organization: runs several projects at once and sets priorities.
• Languages: fluent English.

Preferred qualifications

• Degree in Engineering (Chemical, Mechanical, Electrical, Automation) or a similar field.
• 3 to 5 years of experience as a PM in pharmaceutical or other GMP-regulated manufacturing.
• Hands-on experience with Data Integrity remediation projects.
• PMP, PRINCE2 or IPMA certification.