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Sr Engineer - Manufacturing Execution System (MES)
Job Description
*Depending on experience
Sr Engineer - Manufacturing Execution System (MES)
Let’s do this. Let’s change the world. In this vital role you will be a part of the, 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 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 the 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 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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