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Process Validation Engineer

2 months ago

Rocky Mount, United States Technical Source Full time
Job DescriptionJob Description

Technical Source is currently in search of a Process Validation Engineer for a pharmaceutical client located in Eastern, NC area. The qualified candidate will have experience as a process validation engineer supporting activities in support of cGMP pharmaceutical manufacturing facilities. These activities include working with stakeholders to define process control parameters and process validation protocols to test and verify process robustness.

Basic responsibilities of the Process Validation Engineer include:

• Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes

• Assist with determining the impact of change control on the qualified process and aseptic operations.

• Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.

• Perform all functions associated with process validation support.

• Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.

Minimum Qualifications of the Process Validation Engineer include:

  • 3-10+ years' experience working as Process Validation Engineer in a cGMP environment
  • Experience executing process validation batches for con-commercial batches.
  • Writing and editing protocols
  • Observe line activities and offer support
  • Use company report/protocol templates to enter data generated during assigned batch activities.
  • Ability to work rotating shifts or a steady second shift.

Key Words: process, validation, cGMP, GMP, pharmaceutical, batch, tech transfer, sampling, biotech, protocol, development, execution, stability exhibit, registration, troubleshooting