CQV / Commissioning Qualification Validation Engineer – Italy

Resourcing Life Science; Italia; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A life sciences company in Italy is seeking a skilled CQV professional to plan and execute commissioning activities. The ideal candidate should have 2-3 years of technical experience, strong knowledge of FDA, GMP, and GAMP regulations, and excellent troubleshooting skills. Responsibilities include developing qualification protocols and maintaining detailed documentation. Good English language skills are required. This role is an excellent opportunity to work in a dynamic environment that values precision and adherence to industry standards.

Competenze

• 2-3 years of technical experience as a CQV.
• Strong knowledge of industry regulations (FDA, GMP, GAMP).
• Excellent troubleshooting and problem-solving skills.
• Very good English language skills, both written and spoken.

Mansioni

• Work closely with engineering teams to plan and execute commissioning activities.
• Create detailed commissioning plans, protocols, and reports.
• Conduct thorough checks to ensure equipment is functional.
• Quickly identify and resolve issues during commissioning.
• Develop qualification protocols and comprehensive test plans.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain documentation of qualification tests and analyze results.
• Identify and correct deviations from specifications.
• Work with teams to resolve validation discrepancies.
• Create and implement validation protocols.

Conoscenze

Troubleshooting

Problem-solving

Understanding of FDA regulations

Understanding of GMP regulations

Understanding of GAMP regulations

English language proficiency

Descrizione del lavoro

What to Expect

• Work closely with engineering teams to plan and execute commissioning activities.
• Create detailed commissioning plans, protocols, and reports for production equipment and room qualifications.
• Conduct thorough checks to ensure equipment and systems are fully functional.
• Quickly identify and resolve issues that arise during commissioning.
• Develop qualification protocols and comprehensive test plans for equipment, systems, and processes.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain meticulous documentation of qualification tests and analyze results.
• Identify and correct any deviations from established specifications.
• Work with cross-functional teams to resolve validation discrepancies.
• Create and implement validation protocols for processes and systems, ensuring compliance with industry standards.

Qualifications

• 2-3 years of technical experience as a CQV
• Strong knowledge of industry regulations (FDA, GMP, GAMP).
• Excellent troubleshooting and problem‑solving skills.
• Very good English language skills, both written and spoken