Senior Engineer- MES --PAS X

ACL Digital; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Part time

Job summary

ACL Digital in Thousand Oaks, CA, is seeking a manufacturing support professional focused on Electronic Batch Records (EBR) for Drug Substance manufacturing. You will generate EBRs using PAS-X, validate new records, and assist in MES functionality implementation, coordinating with GMP operations and process development teams.

Preferred candidates have PAS-X experience, knowledge of SAP/PI/DeltaV integrations, and degrees in Chemical Engineering, Biochemistry, Chemistry, Biology, or Computer

Qualifications

• Experience with PAS-X software for electronic batch records (EBR).
• Strong editing and validation skills in PAS-X systems.
• Knowledge of PAS-X integration with SAP, PI, and DeltaV.
• Solid operations knowledge in drug substance manufacturing.
• Ability to work effectively in cross-functional teams.

Responsibilities

• Generate Manufacturing Electronic Batch Records using PAS-X (Korber).
• Validate new Electronic Batch Records (ALM).
• Assist in implementing new MES functionality.
• Develop standard work and practices for MES usage.
• Record NPI/EBR metrics and support continuous improvement.
• Support projects introducing new products and manufacturing tech.

Skills

PAS-X

PAS-X editing/validation

PAS-X integration SAP/PI/DeltaV

Bioprocessing operations knowledge

Team collaboration

Education

Chemical Engineering

Biochemistry

Chemistry

Biology

Computer Science

Job description

Location: Thousand Oaks, CA

Duration: 06 Months

Description:

This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics, and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on Electronic Batch Records for Drug Substance manufacturing.

Top 3 Must Have Skill Sets:

• Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
• Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
• Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing

Must be very experienced in PAS-X

Integration with external program is also a requirement

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
• 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 contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Preferred Qualifications:

• Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
• Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
• Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
• Demonstrated ability to work in a team
• Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Basic Qualifications

Doctorate Degree OR Master Degree and 3 years of Engineering experience OR Bachelor Degree and 5 years of Engineering experience OR Associate degree and10 years of Engineering experience OR High school diploma/GED and 12 years of Engineering experience