Validation Engineer III

Company : Katalyst Healthcares & Life Sciences

Job Description:

• Software qualification experience (specifically for calibration software); equipment/process qualification experience with a preference for experience with temperature mapping (KAYE validator probes).
• Qualified candidates must be experienced in one or more of the following areas of validation:
  • Equipment Qualification.
  • Process Qualification.

Responsibilities:

• Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflicts to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.

• Supervision Received
  Under direct supervision of Manager, Quality Engineering.
• Supervision Exercised:
  No supervisory duties are required.
• To perform this job successfully, an individual must be able to perform each essential duty
  Satisfactorily:
• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
• Generation and execution of software qualification documentation including risk assessment, data integrity checks, trace matrices.
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
• Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
• Develop statistically based sampling plans for in-process and final test sequencing.
• Ensure that all projects are following cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Support and address comments and suggestions associated with validation and engineering documentation.
• Protocol, Deviation, and summary report generation and approval.

Requirements:

• The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
• Bachelor's degree in engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
• 4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
• Demonstrates excellent organizational and communication skills.
• Experience with qualifying medical device manufacturing equipment.
• Results oriented with a strong focus on quality principles and conflict resolution.
• Excellent technical writing skills with a thorough understanding of good documentation practies.
• Experience using temperature mapping equipment including Kaye Validators and Val probes.

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