Description

 OVERVIEW

The Quality Engineer II – Quality Engineering works within the quality team to ensure the overall quality of the equipment and systems used in the manufacturing of products and is tasked with creating documentation and defining system usage acceptance criteria. The Computer System Validation and Equipment Qualification (CSV/EQ) specialist is focused on creating, executing, and maintaining Computer System Validation and Equipment Qualification documentation.

DUTIES AND RESPONSIBILITIES

• Maintains and supports the validation system by:
  • Writing and reviewing validation and qualification documentation.
  • Execution of Validation Documentation of Equipment and Systems
  • Verifying and maintaining records of validation activities.
  • Performing or assisting with periodic reviews of existing validations.
  • Creating the Cleaning Validation Strategy and executing the CV Plan to schedule.
• Maintains and supports the Risk Management system by:
  • Leading or participating in risk assessments related to new equipment and systems.
  • Leading or participating in risk assessments related to changes to equipment and systems.
  • Leading, participating, and maintaining FMEA risk documentation.
• Supports and provides quality guidance and oversight to the Engineering department by:
  • Acting as a primary point of contact for quality questions, concerns, and issues identified by the engineering department.
  • Verify and review quality-related tasks performed by the department.
  • Supporting, assisting, and providing guidance on validation documentation.
• Provides expert assistance and support to the Quality Operations department by:
  • Participating in investigations of system and equipment-related root causes.
  • Providing technical support and coordinating with Engineering to provide technical support for resolving quality issues. 
• Provides expert assistance and support to the Quality Systems department by:
  • Assisting with the evaluation of Change Controls to Processes and Equipment.
  • Assisting in the assurance that new and modified processes remain compliant with regulatory and internal standards, particularly in relation to new equipment and manufacturing processes.
  • Assisting with audit tasks. (Both of Teknova and by Teknova.)
• Represent Teknova and the Quality Organization by:
  • Explain the approach and rationale for validating a system or equipment to a customer or auditor.
  • Demonstrating professional communication when interfacing with production personnel.
  • Demonstrating professional communication when interfacing with external customers.
• Supports continuous improvement by:
  • Improving Quality Engineering-owned policies and procedures.
  • Communicating and escalating observed emerging issues and trends.
• Complete all other work duties as assigned.

Requirements

EDUCATION

• BS/MS in a scientific, engineering, or computer science field.
• CQE certification preferred. 
• Six Sigma Preferred.

KNOWLEDGE / SKILLS / EXPERIENCE

• A minimum of 3 years of experience in qualification/validation activities in a regulated environment. (Preferably in the medical device or pharmaceutical industry).
• Knowledge and experience with the validation of Computer Systems is required.
• Knowledge and experience with GMP and Good Documentation Practices are required.
• Knowledge and experience in ISO 13485 (or comparable FDA regulations) are required.
• Good human relations and oral/written communication skills.
• Ability to handle multiple projects concurrently.
• Stand, walk, bend, carry, push, and use both hands when performing assigned duties.
• Must be able to walk, bend, carry, lift, push, and pull up to 50 pounds

EEO