Plastikon Healthcare is looking for a Validation Engineer. This position coordinates and assists with all process and equipment changes and implementation of new systems, equipment, and product transfers. The Validation Engineer facilitates Process Development meetings, keeping track of validation projects and their status. The Validation Engineer researches new processes and suggests improvement for continued excellence and provides assistance on troubleshooting existing processes and equipment. The Validation Engineer participates in continuous improvement and Kaizen projects in support of the Quality System.

Job Roles required of the position:

Engineer & Validation: Represents engineering and validation for new systems and equipment by providing technical information, writing, and review of URS documents. Supports engineering and validation efforts by performing FAT and SAT commissioning activities. Writes and executes protocols for qualification events. Writes and revises procedures to support new systems or new product realization projects. Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.

  • Apply general engineering principles to develop and implement capital projects that will reduce costs, improve operating efficiency, progress quality, and improve safety.
  • Provide engineering support for new equipment upgrades and special projects.
  • Develop project plans and schedules; estimate time and costs; track project progression.
  • Report on project progress, limiting factors and issues, changes in project scope, develop contingency plans, and resolve issues impeding progress.
  • Collaborate with production personnel to develop new projects, identify limiting factors in current projects, and create/maintain relationships.
  • Assist Product Development with engineering support for new product lines.
  • Ability to work individually and within a team environment.
  • Comply with all company Environmental Health and Safety and Department of Health requirements.

Facility Maintenance: Develops and Generates SOPs for equipment and system maintenance. Actively review reports and documents for compliance to requirements and troubleshoots issues. Provides system/equipment transfer of process to manufacturing/maintenance including provision for training on various systems. Ensures that all systems operate and run in a compliant manner with proper preventive maintenance schedule during validation.

Purchasing: Uses the purchasing system to procure production and maintenance supplies related to validation.

DCR System: Actively uses the DCR System to change or add new document requirements.

CIMP System: Assists Managers and leads projects for continuous improvement and Kaizen events.

NCR System: Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings.

Training: Provides training to other employees to support continued competency.

EDUCATION / EXPERIENCE: Minimum Requirements: BS in Engineering or in another discipline with equivalent experience, with 1+ years hands-on experience with facility validation, processes, and systems. Experience in engineering, ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV).

Skills/Qualifications: Performance ISPE or PDA classwork/training, Management Proficiency, Coaching, Developing Standards, Process Improvement, Decision Making, Troubleshooting, Quality Management, Project coordination and management, P&ID reading, CAD or similar engineering software, commissioning and qualification principles, ISO Systems.

LANGUAGE SKILLS: Required reading, writing, and speaking fluently in English and preparing reports.

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