Validation engineer

Job description

Change Management: Change Control process

• Management of change requests, approvals, implementation, communication, distribution of information.
• Manage, coordinate and follow up changes.
• Perform /initiate change risk analysis.
• Trigger customer communication work-flows, collect information.
• Related document management (SOP, forms, checklists).

Risk Management

• Site risk assessment coordinator.
• Process FMEA responsible.
• Leading risk assessments, coordinating teams.
• Related document management (SOP, forms, risk management tools).

Validation & Qualification

• Equipment qualification according to “V” model: DQ, IQ and OQ.
• Equipment validation as per PQ / PV.
• Participation in projects, being responsible for qualification and validation activities.
• Create validation / qualification document, assign targets for qualification / validation activities.
• Maintenance of validation master program.

Required education and experience

• Engineer, manager or natural science degree (preferred mechanical engineer, technical manager, field of quality engineering)
• 1-3 years quality / testing experience in manufacturing industry (preferred in GMP environment)
• fluent English, good coordination skills
• MS Office, technical writing skill
• Advantages: knowledge of ISO 15378 / GMP and validation / qualification / change- and risk management experience

Location        

• Vas county

Please send your CV to ekler@ekler.hu