Senior Software Engineer - Manufacturing Execution System (MES)

Job Description

Senior Software Engineer - Manufacturing Execution System (MES)

Top 3 Must Have Skill Sets:

• 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.

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.

Summary:

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 our company, 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.

Let's do this. Let's change the world. In this vital role you will be a part of our 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.

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 our network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.

Basic Qualifications:

• Doctorate degree

OR

• 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 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 $66 - $71 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:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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Meet Your Recruiter

Krista McIlwaine

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