Job Details

Job Title: Senior Engineer, MES PAS-X Software - Biopharma - Hybrid (JP13918)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: NPI/EBR Support
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $70 - $78/hour on W2 With benefits
Posting Date: 4/9/2025.
Note: Hybrid - Thousand Oaks, CA - Approximately 1 day per week onsite

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.
Ideal Candidate: 5-10 years of experience.

• Manufacturing Execution System (Kroeber PAS|X) designer / validation experience
• Experience with Enterprise Resource Planning (SAP) software
• Experience with biotech manufacturing (Drug Product process)
• Strong project management skills - This person needs to be comfortable coordinating projects.

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, Rockwell)
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:

• Lack of soft / project management skills to work cross-functionally and develop a project plan
• Lack of ability to be punctual toward the project plan
• Lack of independence / self-starter mentality toward understanding the manufacturing process and imposing electronic batch record requirements around it
• Lack of top 3 skillsets.

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 ...@3keyconsulting.com . 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 www.3keyconsulting.com/careers. 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