Master Batch Records Engineer

Master Batch Records Engineer Fremont, CA 94555 (Hybrid 2 / 3 days per week) 12 Months Minimum Pay Rate: $70/hr on W2

Duties:

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

Skills:

• 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.

About Us: Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:
Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of human connection, defined by our branding attitude of NEWJOBPHORIA , which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential.
Learn more at: ;br />Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.
Notice to California Applicants: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ( CPRA ) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting .