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We are seeking a motivated and detail-oriented Process Engineer with experience in Active Pharmaceutical Ingredient (API) manufacturing to lead the development and implementation of Electronic Batch Records (EBR) . The ideal candidate will bridge the gap between traditional manufacturing processes and digital automation, ensuring compliance, efficiency, and data integrity in our production workflows. Experience with Delta V, POMs (Plant Operations Management systems) , or other automation platforms will be highly advantageous.
Set up and manage Electronic Batch Records (EBR) for API manufacturing
Work with the team to move from paper records to digital systems
Make sure all records follow cGMP and safety rules
Support daily manufacturing operations and solve process issues
Work with automation systems like Delta V or POMs (if experienced)
Help with system testing and documentation (IQ/OQ/PQ)
Train operators on how to use the new electronic system
Degree in Chemical Engineering, Pharmaceutical Engineering, or related field
At least 2-4 years of experience in API manufacturing
Must have experience in developing Electronic Batch Records (EBR)
Knowledge of Delta V, POMs, or other automation systems is a plus
Good understanding of cGMP and data integrity rules
Team player with good communication skills
6 months (renewable based on performance and project needs)
Job ID: 143486627