CSV Engineer
2 months ago
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
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