CSV Engineer

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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance