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Validation Engineer

LanceSoft Inc.
Irwindale, California, United States
April 10, 2019


Job Title:System Development/ Validation Engineer

Job Location: Irwindale CA

Job Responsibilities:

• Coordinate and execute process validation studies, including IQ, OQ, PQ, TMVs, Gage R&R, and Equipment Software Validation as required

• Understand, plan and conduct Design of Experiments, Process Stability / Control / Capability methods, etc. for process characterizations/equipment development, setting parameters.

• Develop process solutions by identifying, testing, and controlling factors that influence product performance and manufacturability

• Interface with quality and manufacturing engineers to review processes, determine validation requirements, and coordinate the validation.

• Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems associated with the validation program.

• Write validation protocols and reports as required

• Coordinate and perform testing relating to the validation

• Administer validation training for the protocol

• Write/update work instructions, part specifications, and various forms of reports and correspondence

• Review the engineering drawings for accuracy

• Create and process Engineering Change Orders (ECOs)

• Utilize advanced statistical tools to determine sampling plans and to analyze data associated with validation activities

• Available for up to 20% travel during critical stages of the projects (both domestic and international)


• Bachelor in Engineering and Science - (Preferred Mechanical or Industrial Engineering)

• Process Characterization (DOE, Capability Study, …) Experience (3+ Years)

• Mechanical System Validation (IQ, OQ, PQ, TMV, G R&R, Equipment Software Validation) Experience (3+ Years)

• Statistical Analysis Tools such as Minitab - Good - 3+ Years

• FDA (21 CFR, Part 820) - Strong Understanding - 2+ Years

Desired Skills:

• Understanding of Catheter Products (Knowledge - 1+ Years)