Validation Specialist

Description

Position Summary & Responsibilities:

The Validation Engineer is responsible for developing, supporting and implementing basic validation initiatives to support the site goals and objectives. The Validation Engineer will be responsible for various validation tasks associated with manufacturing equipment like autoclaves, fillers, ovens, inspection systems, packaging systems etc. In addition provide support to other aspects of validation related to process, test method, software, cleaning, environmental, product, utilities, controlled temperature units (CTUs) etc as required.

• Executes assigned validation projects, with guidance and support from project validation lead/manager. Must employ robust validation principles and practices ensuring that project requirements, risk mitigation, project timelines are achieved in compliance to regulatory requirements and internal company procedures.
• Must be able to work with Autoclaves, Controlled Temperature Units (CTUs), thermocouples and data loggers and have a strong technical writing capability.
• Complete re-qualification and periodic review activities as required per the SVMP schedule.
• Assures validation documentation is generated, reviewed and approved in accordance with documented procedures. Provides validation training to project teams as requested.
• Able to work cross functionally and communicate clearly with Engineering, Manufacturing, Maintenance, QC and R&D teams to prepare, plan and execute and close validation lifecycle documentation in a timely manner.
• Provide validation support to the Change Control process associated with system changes, re-validation and re-qualification initiatives appropriately.
• 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.
• Must support regulatory audits (FDA, MDSAP,ISO, customer audits etc.) and internal audits as needed.

Education, Skills, & Experience:

• Bachelor's Degree in a science or engineering field with 0 years of experience in implementation and validation of manufacturing equipment and associated computer systems
  • Associate Degree with 2+ years of validation experience in implementation and validation of manufacturing equipment and associated computer systems
  • High School Diploma or GED with 4+ years of validation experience in implementation and validation of manufacturing equipment and associated computer systems
• Good communication and writing skills. Knowledge and application of current validation regulations, guidance and processes.
• Proficient in Microsoft Office Suite and validation software.
• Knowledge of GMP regulations and validation guidelines.
• Knowledge and experience in writing protocols and following procedures.
• Ability to stand for prolonged period of time, ability to lift and move validation related equipment during validation executions as required.

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