GMP Manufacturing Execution System

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: GMP Manufacturing Execution System (MES) Specialist

Location : Berkeley, CA

Duration : 12 Months

Immediate/Phone Hire !!!!!!!!!!

Support site Manufacturing Execution System (MES) by creation/revision of electronic Master Batch Records (MBRs), support system training and interface between end users and system owners and cross-functional departments.

POSITION SUMMARY:

Special skills are required to establish and maintain content for site Manufacturing Execution System to support and collect data for day to day operation of the manufacturing of product.

POSITION DUTIES & RESPONSIBILITIES:

• Create / revise MBRs

• Create MES system and MBR specific training materials

• Determine MBR test plans

• Review/disposition MBR test results

• Approval of MBRs with proposed effective dates

• Provide MES/MBR training

• Ensure training system LMS is properly updated for MES related items - interact / communicate with impacted departments

REQUIREMENTS/PREFERENCES Education Requirement(s)

• Minimum Experience: BS 4+ years, MS 0-2+ years or an equivalent combination of education and experience

• Special Skill/Knowledge - MES system knowledge

• Manufacturing process knowledge

• Knowledge of interaction with external systems (DCS, SAP, ECS)

• Ability/knowledge to write test plan and build test data

• Knowledge of review by exception

• Knowledge of creating training material

• Communication and training skills

• Knowledge of change control process