What are the responsibilities and job description for the CSV Engineer position at Katalyst Healthcares & Life Sciences?
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.
- 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.
