Sr Engineer - Software

Crystal Equation Corporation; Thousand Oaks (CA); On-site; USD 79,000 - 85,000; Full time

Benefits offered by this job

Full benefits

Paid time off

401K

Parental leave

Job summary

Crystal Equation Corporation seeks a Sr Engineer - Software onsite in Thousand Oaks, CA. You will generate electronic batch records (EBR) using PAS-X, validate GMBRs in GMP settings, and contribute to MES enhancements (EQM, MBR elements) while aligning with cross-functional teams.

You will develop standard work, participate in Lean initiatives, and drive NPI/EBR metrics across the plant. The role requires collaboration with process development and GMP operations, with full benefits provided.

Qualifications

• PAS-X software experience for electronic batch records.
• GMBR design knowledge in GMP environments; validation of records.
• Experience integrating MES with enterprise systems (SAP, PI).

Responsibilities

• Generate Manufacturing Electronic Batch Records (EBR) using PAS-X.
• Validate new Electronic Batch Records (GMBR) within GMP.
• Assist in implementing new MES functionality (EQM, MBR elements).
• Develop standard work for MES processes and EBR workflows.
• Support Lean Transformation by tracking NPI/EBR metrics and driving improvements.
• Participate in projects introducing new products and manufacturing tech.
• Collaborate across distributed teams to align EBR standards.

Skills

PAS-X

GMP knowledge

SAP integration

DeltaV

Rockwell

Education

Engineering/CS degree

Tools

SAP

PI

DeltaV

Rockwell

Job description

Sr Engineer - Software Onsite

What you will do

Lets do this. Lets change the world. In this vital role you will be a part of the Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of New Product Introductions / Electronic Batch Record metrics and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on future-proofing and global transformation of Electronic Batch Records for Drug Product manufacturing.

Job scope and responsibilities

• Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
• Validation of new Electronic Batch Records (Application Lifecycle Management)
• Assisting in implementation of new MES functionality (Equipment Management (EQM), PCS MBR Elements)
• Develop standard work and business practices for new MES functionality
• Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
• Participate and contribute to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
• Engage with the rest of the network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.

Preferred Qualifications

• Skilled with PAS X (Korber) software for electronic batch records with detailed understanding of GMBR design Experience with validation of GMBRs in a GMP environment Knowledge of PAS-X integration with external programs (SAP, PI, DeltaV, Rockwell)
• Strong operations knowledge of drug product manufacturing and a broad understanding of related disciplinary areas in bioprocessing Demonstrated ability to work in a distributed team Demonstrated ability to manage project deliverables and proactively engage with project stakeholders
• Degree in Chemical Engineering, Bioengineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Pay range is $57 - $62 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE

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