Sr Engineer

Hybrid - Thousand Oaks, CA - Approximately 1 day per week onsite.

Ideal Candidate: 5-10 years of experience.

• Manufacturing Execution System (Kroeber Client X) designer / validation experience - Candidates should be SME's in this

• Experience with Enterprise Resource Planning (SAP) software

• Experience with biotech manufacturing (Drug Product process)

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Client, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Manufacturing

Sr Engineer - Manufacturing Execution System (MES)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be a part of the Client, 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 Client-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 Client network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master's degree and 4 years of MES experience Or

Bachelor's degree and 6 years of MES experience Or

Associate's degree and 10 years of MES experience Or

High school diploma / GED and 12 years of MES experience

Preferred Qualifications:

Skilled with Client X (Korber) software for electronic batch records with detailed understanding of GMBR design

Experience with validation of GMBRs in a GMP environment

Knowledge of Client-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