Overview
On Site
Full Time
Skills
Business Requirements Gathering
Risk Assessment
Traceability Matrix
Software Development Methodology
Standard Operating Procedure
Forms
Documentation
Science
Electrical Engineering
Technical Training
Pharmaceutics
Supervision
EMS
Element Management System
Computerized System Validation
SCADA
Wonderware
Data Integrity
GAMP
Communication
Microsoft Office
Art
Research
Manufacturing
Internet
Microsoft Outlook
Microsoft PowerPoint
Microsoft Excel
Adobe Acrobat
SAP BASIS
Management
Decision-making
Cross-functional Team
GLP
GMP
Job Details
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.
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