Commissioning and Qualification Engineer

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL

3d•$85,000 - $95,000•Onsite

About The Position

Under general direction, this role involves writing, executing, reviewing, and approving equipment commissioning and qualification protocols. The engineer will also configure and execute Design of Experiments, perform statistical analysis of test data, write equipment and material specifications, and conduct engineering investigations related to equipment, materials, and facilities issues.

Requirements

Bachelor’s Degree in engineering discipline.
Knowledge of GMP, CFR, ICH.
Knowledge of Statistics and Data Analysis.
Knowledge of Project Management.
Knowledge of Production equipment, instrumentation, and automation.
Knowledge of Commissioning and Qualification.
Ability to interpret and apply Federal, state and local policies, procedures and regulations.
Ability to respond to inquiries from management, employees and regulatory agencies.
Ability to perform engineering investigations, analyze and troubleshoot problems, identify solutions, and manage CAPAs.
Ability to perform statistical analysis, DoEs, and summarize data.
Proficient in the use of Microsoft Word, Excel, Project, and Minitab.
Ability to create, plan and implement goals, objectives and practices.
Ability to manage multiple projects, duties and assignments.
Ability to communicate clearly and concisely, both orally and in writing.
Ability to establish and maintain cooperative working relationships with others.
Two years of experience in commissioning and qualification.
Experience in the pharmaceutical or Medical Device industry.

Nice To Haves

Master’s Degree preferred.
ASQ Quality Engineer Certification (CQE) 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 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.