Field Assurance Engineering Technician

Description

The incumbent will be responsible assisting Field Assurance Engineers with complaint samples and assist with writing findings.

Essential Job Functions

• Maintain biohazard and decontamination lab. Responsible for ordering supplies, maintaining inspection tooling, shipping samples, maintaining inventory, performing safety checks, and cleaning lab.
• Perform decontamination on samples received from the field.
• Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
• Maintains a professional working relationship with internal and external customers and support staff.
• Assists in developing physical and functional test requirements to ensure specifications and regulations are met.
• Develops a working knowledge of, and assists in the completion of, Risk Assessments/FMEA, Design Verification/Validation Test Plans, and Process Validation Master Plans.
• Conducts testing outlined in protocols.
• Executes validation testing on equipment and processes.
• Trains on, understands and follows company procedures and regulatory requirements.
• Participates in and provides input to training on department and division procedures, and policies.
• Participates in project planning, scheduling and tracking.
• Plans and coordinates engineering test builds (e.g., inspection and testing).
• Analyzes design, process and test development problems.
• Must have technical writing skills.
• Familiar with biohazard and/or cleanroom laboratory environment (bio-hazard gown).

Basic qualifications

• Detail-oriented.
• Organizational skills.
• Computer-savvy skills.
• Multi-tasking skills.
• Technical writing skills.
• Basic interpersonal skills – active listening.
• Software application skills.
• Basic problem-solving / troubleshooting skills.
• Oral and written presentation skills.
• Ability to work in cross-functional teams.
• Basic descriptive statistics.
• Collection and analysis of data.
• Perform testing per written directions.
• Ability to read engineering drawings.
• Lab Safety Skills.

Education/Experience

• Medical industry (GMP) experience preferred.
• Proficient in Microsoft Office preferred.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.
• The employee frequently is required to talk and hear.
• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.