CSV Engineer – Katalyst Healthcares & Life Sciences

Title of the Job: CSV Engineer

Location: Los Angeles, CA

Job Description: Responsibilities:

• Lead the development and approval of validation documentation, risk assessments, etc.
• Work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
• Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
• Able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
• Must be able to create, review, and update SOPs, forms, templates, documentation and files.
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
• Perform other duties as assigned.

Requirements:

• Bachelor of Science, Electrical Engineering, or equivalent technical training.
• Minimum -5 years of working knowledge and expertise in computerized systems validation in biotech or pharmaceutical organization.
• Ability to work with minimal direct supervision: meet deadlines, prioritize assignments, provide recommendations and effectively communicate updates.
• Must have Sunbelt Client/EMS experience.
• Computer System Validation experience with DCS, SCADA and Client systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
• Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
• Excellent written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
• Must be proficient with Internet navigation, Microsoft Office (Outlook, Word, PowerPoint, Excel, Project, Teams, Sharepoint), Adobe Acrobat
• Should be flexible to working outside the core business hours (occasionally on short notice, and a limited basis), as needed.
• Proven ability to manage multiple and fast-moving priorities.
• Ability to work well in a fast-paced collaborative team environment within a rapidly evolving business environment.
• Skilled at solving multi-dimensional problems with both quantitative and qualitative variables.
• Ability to lead and influence others in support of company objectives.
• Excellent decision making and cross functional team building skills.
• Solid understanding of GMP, GLP, and non-GMP project requirements
• Able to read and understand engineering plans and specifications.
• Demonstrated ability to build strong working relationships.

Company Name: Katalyst Healthcares & Life Sciences

Salary:

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