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Validation Engineer III
4 months ago
Summary: BioPharma Consulting JAD Group is seeking a Validation Engineer III to join our team. As a Validation Engineer III, you will be responsible for planning and executing validation activities for pharmaceutical manufacturing processes and equipment. The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols as well as preparing validation final reports for the same. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
Functions:
- Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements.
- Under guidance from Sr. Validation Engineers-Specialists /Validation Manager, 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. Validation Engineers-Specialists /Validation Manager (author protocol, execute, analyze data, author reports).
- Must be able to review all FUSE 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 review, and update SOPs, forms, templates, documentation, and files.
- Performs 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.
Required Skills & Abilities:
- Significant working knowledge of engineering principles.
- Strong working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.
- Efficient Knowledge ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.
- Solid written and oral communication skills.
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
- Ability to work with general guidance from Sr. Validation Engineers-Specialists /Validation Manager.
- Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
Requirements
- Qualifications:
- Master’s Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or
- Bachelor’s Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or
- Associate's Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology, or
Preferred Qualifications:
- Degree in Engineering or Science Discipline.
- Experience preferably in FDA-regulated environments.
