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Sr. Business Analyst Lead (SAP, MES, LIMS)

C

Celere, Inc.

Sr. Business Analyst Lead (SAP, MES, LIMS)

Pleasanton, CA
Full Time
Paid
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  • Responsibilities

    Job Description

    JOB TITLE: Sr. Business Analyst Lead (SAP, MES, LIMS)

    JOB LOCATION: Pleasanton, CA USA

    JOB DUTIES: Seeking a Senior Business Analyst (BA) Lead to join our growing team as part of a Medical Device/Pharma company. This is a key and high level role and may lead a BA team of 2-5 members. We are looking for experienced individual in the Medical Device/Diagnostic/Pharmaceutical industry that is an excellent communicator and can effectively lead teams including cross-functional members.

    • 10+ years years experience working in the Pharmaceutical "Cell Culture Manufacturing" area/facility (production, warehousing, quality control, manufacturing QA)

    • 10+ years extensive experience with SAP (materials management, manufacturing, QM modules), MES and LIMS (Emerson/DeltaV)

    • Direct experience with validation of SAP, MES, LIMS (and related experience in GMP Cell Culture facilities.)

    • Extensive business process/requirements facilitation experience (large group facilitation)

    • Experience with defining detailed integration specifications

    The individual will need to manage all aspects of manufacturing process/requirements definition - responsible for delivering process decomposition, process flows, requirements, functional specifications, and detailed design.

    Will lead a team of BA's to perform this work, and will have to coordinate across several facilities (i.e. pull in manufacturing, engineering, warehousing, QC, QA) to develop a comprehensive set of requirements.

    EDUCATION & EXPERIENCE: Minimum of a Bachelor’s degree in Engineering (E.g. Chemical Engineering, Mechanical Engineering, Biomedical Engineering) or a related field plus 10+ years related experience (primarily in cell-culture facility.) Advanced degree such as MBA a plus.

    SPECIFIC SKILLS OR OTHER REQUIREMENTS: EXPERIENCE MUST INCLUDE:Knowledge and working application of FDA and cGMP requirements, Validation principles and guidelines and industry practice, Technical Writing including requirements gathering, Standard Operating Procedures, and Project Management.

    Company Description

    https://www.celereinc.com