CQ Engineer: Commissioning, Qualification & Validation

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 85,000 - 125,000; Full time

Job summary

Aveva Drug Delivery Systems in Fort Lauderdale, FL, is seeking an engineer to write, execute, or review equipment commissioning and qualification protocols, configure and execute Design of Experiments, and analyze test data to support compliant manufacturing operations.

You will collaborate with Quality Assurance and suppliers to develop materials specifications, resolve process issues, and maintain validated states while adhering to GMP, CFR, and ICH guidelines.

Qualifications

• Bachelor’s degree in engineering discipline; Master’s degree preferred.
• Two years of commissioning and qualification experience in pharmaceutical or medical device industry would be advantageous.
• ASQ CQE certification is a plus.

Responsibilities

• Perform investigations into equipment failures, materials issues, procedural issues, or process problems.
• Write and execute commissioning and qualification protocols on equipment and facilities.
• Support the implementation and documentation of CAPAs and corrective actions.
• Review and approve documents, procedures, protocols, and reports.
• PerformPeriodic Qualification Certifications to maintain system qualification state.
• Collaborate with QA and suppliers to develop materials specifications and improved processes.
• Identify root causes and develop cost-effective solutions to prevent recurrence.
• Identify opportunities to improve commissioning and qualification programs while ensuring compliance.
• Ensure compliance with company policies, safety rules, and regulatory requirements.

Skills

GMP & regulatory knowledge

Statistics & data analysis

Project management

Commissioning & qualification

Problem solving & CAPAs

Communication skills

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

MS Project

Excel

Word

Minitab

Job description

Aveva Drug Delivery Systems in Fort Lauderdale, FL, is seeking an engineer to write, execute, or review equipment commissioning and qualification protocols, configure and execute Design of Experiments, and analyze test data to support compliant manufacturing operations.

You will collaborate with Quality Assurance and suppliers to develop materials specifications, resolve process issues, and maintain validated states while adhering to GMP, CFR, and ICH guidelines.