| CSV Engineer-Baltimore-Maryland-Hybrid at Maryland, New York, USA |
| Email: [email protected] |
| From: Gulshan, Stellent IT [email protected] Reply to: [email protected] CSV Engineer Baltimore, Maryland-Hybrid Phone+Skype 6+Month Job Description Senior CSV Engineer/Analyst Responsibilities: MODA Direct experience and understanding of complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators Experience with lab system configuration and operation Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations Independently understanding clients quality standards, cGMPs, and regulatory standards to support team in compliance of validation effort Independent verification of testing against specifications Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows Product Owner/Admin for Micro EM MODA Oversee delivery of a validated GMP solution to a global user community Collaborate with site laboratory operations subject matter experts (SMEs) to deliver a solution built upon a harmonized business process aligned with quality standards and site-specific monitoring procedures. Oversee root cause analysis and vendor collaboration on technical issues to promote solution performance. Ability to create a Standard Operating Procedure (SOP) for site master data configuration, migration, and verification. Support the creation and delivery of global training materials for EM MODA. Create business requirements and user stories, performing product backlog creation and refinement. Work with cross-functional teams represented by site, vendor, and global teams to provide on-going support of a user community of practice. Technical lead responsible for managing enhancement and bugfix testing, validation, and release of EM MODA Must be willing to work onsite in Baltimore, MD Bachelors Degree or equivalent required Demonstrated experience in leading CQV activities specific to Process Equipment Proficiency using PC and Microsoft Office tools Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms Ability to work as part of a team Strong problem-solving and critical thinking skills Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice Keywords: information technology green card Maryland CSV Engineer-Baltimore-Maryland-Hybrid [email protected] |
| [email protected] View all |
| Fri Sep 13 01:15:00 UTC 2024 |