Commissioning and Qualification Engineer I

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

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.