Commissioning and Qualification Engineer

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems in Fort Lauderdale, Florida, is looking for a qualified individual to focus on equipment commissioning and qualification. The role involves writing protocols, performing statistical analysis, and ensuring compliance with safety regulations.

The ideal candidate will hold at least a Bachelor’s Degree in engineering and have experience in the pharmaceutical or medical device industries. Strong knowledge of GMP and project management is also crucial for success in this position.

Qualifications

• Two years of experience in commissioning and qualification, preferably in the pharmaceutical or medical device industry.
• ASQ Quality Engineer Certification (CQE) is a plus.

Responsibilities

• Perform investigations into equipment failures, materials issues, and process problems.
• Write and execute commissioning and qualification protocols on equipment and facilities.
• Support documentation of Corrective and Preventive Actions (CAPA’s).
• Review and approve documents and procedures.
• Perform Periodic Qualification Certifications.
• Work with Quality Assurance on materials specifications and improved processes.
• Identify root causes of problems and develop cost-effective solutions.
• Enhance the commissioning and qualification program.
• Ensure compliance with all Company policies and procedures.

Skills

GMP, CFR, ICH

Statistics and Data Analysis

Project Management

Production equipment, instrumentation, and automation

Commissioning and Qualification

Statistical analysis

Proficient in Microsoft Word, Excel, Project, Minitab

Education

Bachelor's Degree in engineering discipline

Master's Degree

Job description

Description

Job Summary: Under general direction will write, execute, or review and approve equipment commissioning and qualification protocols, configure and execute Design of Experiments, perform statistical analysis of test data, write equipment and material specifications, and perform engineering investigations regarding equipment, materials, and facilities issues.

Job 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 Corrective and Preventive Actions (CAPA’s).
• Review and approve documents, procedures, policies, protocols, engineering studies, and reports.
• Perform Periodic Qualification Certifications to ensure that the qualified state of the system in question is maintained or reinstated.
• Work with Quality Assurance and suppliers to develop materials specifications, improved processes, and resolution of problems related to components, processes and equipment.
• Identify the root cause of problems and develop recommendations for cost effective solutions to prevent the problem from reoccurring.
• Identify opportunities to improve the commissioning and qualification program while assuring or enhancing the state of compliance.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

Qualifications

Education

• Bachelor’s Degree in engineering discipline. Master’s Degree preferred.

Knowledge, Skills And Abilities

• GMP, CFR, ICH.
• Statistics and Data Analysis.
• Project Management.
• Production equipment, instrumentation, and automation.
• Commissioning and Qualification.
• Interpreting and applying Federal, state and local policies, procedures and regulations.
• Responding to inquiries from management, employees and regulatory agencies.
• Performing engineering investigations, analyzing and troubleshooting problems, identifying solutions, and managing CAPAs.
• Statistical analysis, DoEs, summarizing data.
• Proficient in the use of Microsoft Word, Excel, Project, and Minitab.
• Creating, planning and implementing goals, objectives and practices.
• Managing multiple projects, duties and assignments.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining cooperative working relationships with others.

Experience

• Two years of experience in commissioning and qualification. Experience should be in the pharmaceutical or Medical Device industry. ASQ Quality Engineer Certification (CQE) is a plus.