Job Title: MES MBR Designer

Location: Fremont, CA

Hours/Schedule: Hybrid- 1st Shift: Mon-Fri, 8:00AM-5:00PM

Compensation: $95.00- $106.00

Type: (contract, contract to hire or direct)

Overview

Join one of the worlds largest pharmaceutical company that is driven by science and are seeking to push the boundaries of what's possible in medicine and explore new options in life-enhancing treatments.

Responsibilities

• The MBR designer is responsible for understanding all the complexities of the BioMES system, revise and design new electronic batch records, troubleshoot EBR issue and lead continuous improvement initiatives relative to BioMES.

• This position is also responsible for the overall business process and improvement topics relative to electronic records.

• This position is expected to understand the nuances of the highly complicated electronic system.

• This position utilizes LEAN tools to systematically evaluate information flow, create project plans and drive right first-time success.

• The MBR designer trains modelers to learn how to generate batch records, generates and refines batch record creation training materials and troubleshoots EBRs.

• The MBR designer works with client groups (Process Engineers, Operations, Quality) to determine design changes and improvement opportunities within the scope of electronic batch records and leads the team to prioritize and implement said improvements.

• This role is required to work with industry experts to stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business.

• The MBR designer leads and participates in project teams and works within BioPharma BioMES team to standardize business processes.

  Requirements

• Subject matter expert relative to manufacturing and MES Master Batch Records.

• Ability to transform/translate process information/design from process description into a MES Master Batch Record.

• Experience working in multiple projects simultaneously.

• Technical writing skills.

• Technical knowledge of manufacturing systems, methods and procedures, biopharmaceutical manufacturing processes, knowledge of regulatory aspects (cGMP).

  Education:

• Professional training or Associates/Bachelor’s degree in STEM, IT or equivalent.

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

  #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.