Summary: Seeking a CSV Engineer/Analyst MODA to oversee validation and delivery of GMP solutions, manage lab systems, and support compliance with quality standards.

Requirements:

Bachelor's Degree or equivalent

Direct experience with automated lab systems (HPLC, GC, TOC, UV/Vis, Plate Readers)

Experience with lab system configuration and operation

Understanding of system integrations and data flow

Knowledge of cGMPs and regulatory standards

Proficiency in PC and Microsoft Office tools

Preferred Skills:

Experience leading CQV activities for Process Equipment

Intermediate skills with WORD; basic skills with EXCEL and PowerPoint

Familiarity with bench top analytical equipment, chromatography, LIMS sample workflows

Responsibilities:

Oversee delivery of validated GMP solutions to global users

Collaborate with SMEs on harmonized business processes

Perform root cause analysis and vendor collaboration for technical issues

Create SOPs for site master data configuration, migration, verification

Support creation and delivery of global training materials for EM MODA

Manage enhancement/bugfix testing, validation, release of EM MODA

Pay Details: $31.00 to $42.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance