06 ott - Parma
Chiesi
OverviewIn this role, you will oversee the site's validation and qualification activities to ensure products meet quality and regulatory standards.
You will lead the Validation Program across equipment, processes, utilities, and systems, aligning with cGMP and regulatory expectations.
You'll collaborate with QA, QA Validation, and EHS to sustain data integrity and risk-based validation strategies.
This position offers impact on end-to-end manufacturing quality and continuous improvement within a global tech ops context.
You'll work with cross-functional teams to shape compliant, efficient validation practices and support site projects.
Retribuzione / Benefitspension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
annual premio
ResponsabilitàSupport budget and resource planning for departmental projects
Define and maintain organizational structure, roles, and objectives aligned with MBO
Promote team development through training and coaching
Ensure personnel compliance with values, conduct, and regulatory requirements
Oversee personnel management, safety, and maintenance planning
Govern health and safety obligations and collaborate with EHS on risk assessments
Implement risk controls, emergency procedures, and PPE protocols
Lead validation activities by setting objectives, timelines, and corrective actions
Coordinate equipment lifecycle management including qualification, maintenance, and calibration
Review and approve validation documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV)
Investigate qualification deviations and assess regulatory impact
Manage environmental and cleaning validation programs
Ensure GDP-compliant pharmaceutical transport validation
Support new site projects with qualification strategies
Contribute to process verification planning and documentation
Drive CAPA and continuous improvement in validation processes
Participate in regulatory inspections and audits
Lead Validation Master Plan and VMS documentation
Deliver training on Validation, Qualification, and Change Management processes
Requisiti fondamentaliBachelor's or Master's Degree in scientific or engineering discipline
8–10 years of pharma/biopharma manufacturing experience
Extensive experience in validation and qualification in cGMP environments
Strong knowledge of EU and FDA regulatory requirements with exposure to inspections
Proven background in managing validated/qualified systems
Ability to manage multiple projects with strategic execution
Strong technical problem-solving and risk assessment skills
High initiative, accountability, and ability to work with minimal supervision
Excellent teamwork and interpersonal skills
team leadership
cross-functional collaboration
proactive communication
Validation, Qualification & Compliance
CSV (Computerized System Validation)
Data Integrity
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