Senior Engineer, MES PAS-X Software - Biopharma - Hybrid

Job Title: Senior Engineer, MES PAS-X Software - Biopharma - REMOTE (JP13409)

Location: Thousand Oaks, CA. 91320 (REMOTE)

Business Unit: NPI/EBR Support

Employment Type: Contract

Duration: 1+ years with possible extension or conversion to FTE

Rate: $70 - $78/hour. Will consider higher rate for qualified candidate. With benefits

Posting Date: 11/15/2024.

Note : Local preferred but can be remote

3 Key Consulting is hiring! We are recruiting a Senior Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

Support Drug Substance Supply organization. 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.

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. Top Must Have Skill Sets:

MUST have strong PAS-X software experience 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

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

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

Red flags:

No PAS-X experience

Unable to speak to the experience listed on their resume

Why is the Position Open?

Supplement additional workload on team

Interview Process:

1) Phone Screening (Logistics and General knowledge questions)

2) Panel Interview

We invite qualified candidates to send your resume to . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Regards,

3KC Talent Acquisition Team