Senior Engineer: MES, EBR & GMP Validation (Onsite)

Akraya, Inc.; Thousand Oaks (CA); On-site; USD 76,000 - 83,000; Full time

Job summary

Akraya is seeking a skilled MES/EBR professional to support drug product manufacturing at our Thousand Oaks, CA site. The role focuses on creating and validating electronic batch records, ensuring seamless integration with production systems, and driving continuous improvement across the manufacturing process.

You will implement new MES functionality, develop standard work for MES features, and track NPI/EBR metrics to support global transformations within the drug product supply chain.

Qualifications

• MES PAS|X experience.
• Detail-oriented approach to translate process parameters into EBRs.
• Continuous Improvement mindset.
• Experience in the biotechnology or pharmaceutical industry, specifically within drug product manufacturing and GMP environments, is highly preferred.

Responsibilities

• Generate and validate electronic batch records.
• Assist with new MES functionality implementation.
• Develop standard work for MES features.
• Track NPI/EBR metrics for continuous improvement.
• Facilitate communication between GMP operations and science groups.

Skills

Electronic Batch Record Software

GMP Validation

PAS X

Korber

GMBR

MES Configuration

Process Improvement

Cross-Functional Communication

Job description

Akraya is seeking a skilled MES/EBR professional to support drug product manufacturing at our Thousand Oaks, CA site. The role focuses on creating and validating electronic batch records, ensuring seamless integration with production systems, and driving continuous improvement across the manufacturing process.

You will implement new MES functionality, develop standard work for MES features, and track NPI/EBR metrics to support global transformations within the drug product supply chain.