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Validation Engineer
3 months ago
The Validation Engineer, under general direction, will be responsible for drafting and executing validation protocols for (FUSE) Facilities, Utilities, Systems and Equipment, as well as preparing validation final reports for the same.
Essential 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 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.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Working on ladders.
- Attendance is mandatory.
Qualifications:
- Master’s Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Bachelor’s Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Associates Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Preferred Qualifications:
- Degree in Engineering or Science Discipline.
