bioMérieux SA Hiring for Associate Validation Engineer at Durham Full Time

Position:  Associate Staff Validation Engineer

Description

Develops, supports and implements the commissioning, qualification, and validation activities for high throughput manufacturing formulation, filling, and capping operations. Additionally, develop, support, and implement validation initiatives as defined in site goals and objectives. Responsible for various validation tasks within the validation lifecycle (Validation types include equipment, software, cleaning, environmental, process, product, etc.).

Primary Responsibilities:

• Executes assigned validation projects, with guidance and support from project validation lead/manager. Depending on level of seniority, employs robust validation principles and practices assuring project requirements, risk mitigation, project timelines and compliance to regulatory requirements and internal procedures are achieved.
• Assures validation documentation is generated, reviewed and approved in accordance with documented procedures. Provides validation training to project teams as requested.
• Supports Change Control processes in support of system changes, re-validation and re-qualification initiatives
• Supports supplier and internal audit initiatives related to validation activities.
• Participates in project planning activities in support of validation tasks and communicates validation status. As necessary, raises issues and concerns during project lifecycle.
• Develops, reviews and leads the execution of Validation Plans and activities in accordance with documented procedures.

Education, Skills, & Experience:

• Bachelor’s Degree with more than 7 years of work experience. Must be able to lead validation activities at a global level.
• Good communication and writing skills. Knowledge and application of current validation regulations, guidance’s and processes.
• Ability to work as a team member on cross functional teams executing complex project implementations. Strong technical writing skills.
• Knowledge of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, EU, GAMP, FDA, etc.).
• Ability to use common software tools and to learn and apply new validation methodologies as needed on assigned projects and tasks. Six Sigma experience (Yellow Belt, Green Belt).
• Ability to participate on risk assessment teams. Primarily responsible for working in a team environment with some validation leadership responsibilities.

This position is responsible to help select technology with the least implementation risk, lead the development of validation strategy, and to develop and execute protocols required to validate the technology. This position leads risk based decision making and identifies the risks and benfits when trade-off determinations are required.

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