Remote Validation & Equipment Compliance Lead (CSV)

Chiesi; Parma; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Pension

Private medical insurance

Remote work options

Job summary

Chiesi seeks a senior Validation & Compliance leader to oversee site validation, qualification activities and CSV governance across equipment, processes, utilities, and computerized systems. You will drive risk-based validation strategies, partner with cross-functional teams, and shape site quality programs while ensuring regulatory alignment and continuous improvement.

This role offers impact within a global manufacturing network and opportunities to lead VPP/validation documentation, with

Qualifications

• 8-10 years of experience in pharma or biopharma manufacturing.
• Extensive experience in validation and qualification of equipment and systems in cGMP environments.
• Strong knowledge of EU and FDA regulatory requirements; exposure to regulatory inspections (FDA/DEA).
• Ability to define and execute multi-project strategies.
• Solid technical problem-solving and risk assessment skills.

Responsibilities

• Oversee site validation and qualification activities to ensure products meet quality standards within GMP guidelines.
• Lead validation/qualification activities with objectives and timelines; review data and corrective actions.
• QA review of validation docs (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) and regulatory compliance.
• Collaborate with Production to align GMP and production plans; support CAPA from audits/inspections.

Skills

Leadership

Team collaboration

Communication

Risk assessment

Problem solving

GMP knowledge

CSV/Validation

Regulatory awareness

Tools

VPP

VFR

CSV

Job description

Chiesi seeks a senior Validation & Compliance leader to oversee site validation, qualification activities and CSV governance across equipment, processes, utilities, and computerized systems. You will drive risk-based validation strategies, partner with cross-functional teams, and shape site quality programs while ensuring regulatory alignment and continuous improvement.

This role offers impact within a global manufacturing network and opportunities to lead VPP/validation documentation, with