CQV / Commissioning Qualification Validation Engineer – usa

Resourcing Life Science; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

A life sciences company in the United States is looking for a CQV professional with 2-3 years of experience. Responsibilities include developing commissioning plans and ensuring compliance with FDA and GMP regulations. Strong troubleshooting skills and proficiency in English are required for this role.

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.

Responsibilities

• 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.

Skills

Troubleshooting skills

Problem-solving skills

Knowledge of FDA regulations

Knowledge of GMP

Knowledge of GAMP

English (written and spoken)

Job description

Responsibilities

• 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