Validation & Equipment Compliance Manager
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In 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 / Benefits- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- relocation support
- annual bonus
- Support 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
- Bachelor’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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