Quality Assurance Validation Specialist
2 weeks ago
Job Title: Validation Engineer - Pharma
Company: Premier Life Sciences LLC
Role Overview: The Validation Engineer is tasked with the formulation and execution of validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE) under general oversight. This position involves the preparation and completion of validation final reports for these systems.
Key Responsibilities:
- Develop, secure approval for, and implement validation deliverables, including Validation Plans, System Impact Assessments, User Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Performance Qualifications, and Validation Final Reports, ensuring adherence to regulatory and procedural standards.
- Coordinate and manage validation activities across various functional teams, guided by senior validation engineers or the validation manager, while providing updates on validation progress.
- Independently draft protocols, carry out validation tasks, analyze results, and compile reports with minimal supervision.
- Evaluate FUSE System Delivery Life Cycle (SDLC) deliverables, offer constructive feedback, and ensure compliance with Standard Operating Procedures (SOPs).
- Review and revise SOPs, forms, templates, documentation, and files as necessary.
- Conduct responsibilities in a compliant and ethical manner, aligning with all relevant laws, regulations, and industry standards.
- Undertake additional responsibilities as assigned.
Required Skills & Qualifications:
- Solid understanding of engineering principles.
- In-depth knowledge of FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, and Temperature-Controlled Units (2-8°C, -80°C, LN2 Freezers, Incubators).
- Familiarity with ISPE Baseline 5, Vol. 2 – Commissioning and Qualification, and FDA industry regulations.
- Strong written and verbal communication abilities.
- Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Capability to work under general guidance from senior validation engineers or the validation manager.
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