Validation Specialist Engineering
About The Position
The Specialist, Validation, will be responsible for completion of validation execution activities at the West Point site as part of the Bio-Sterile Validation (BSV) team. The primary responsibility of the individual will be providing validation support to the Integrated Product Teams (IPTs). The Specialist will prepare, review, approve and execute validation documentation (including but not limited to; protocols, periodic assessments, and final reports) related to new or existing manufacturing projects to ensure successful completion is in alignment with West Point validation requirements. Also, when required the Validation Specialist will be required to train other Validation personnel. Additional responsibilities include the following: · Manage validation needs and deliverables for ongoing Validation activities as assigned to specialist. · Work closely with IPT management to ensure safe, on-time, and correct execution of validation activities. · Interface with site Validation SMEs to ensure validation practices are aligned with our Company network. · Support site IPTs during investigations and troubleshooting. · Support all aspects of the Continuous Validation Program
Requirements
- BS, Preferably in Engineering or Sciences
- Minimum of 2 years of relevant work experience, hands on experience on validation activities on sterile products manufacturing.
- Knowledge and hands on experience with Validation processes.
- Familiarity of different types of Validation applications.
- Familiarity of compliant validation testing techniques.
- Strong communication, collaboration skills and ability to drive accountability.
- Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
- Adaptability
- Applied Engineering
- Automation
- Collaborative Communications
- Data Analysis
- Documentation Review
- Equipment Troubleshooting
- Good Manufacturing Practices (GMP)
- Microsoft Office
- Process Optimization
- Production Operations
- Professional Integrity
- Project Management
- Root Cause Analysis (RCA)
- Technical Writing
- Technology Transfer
- Vaccine Manufacturing
- Validation Testing
- Writing Technical Documents
Nice To Haves
- Experience working on cross-functional team to achieve common goal.
- Experience writing validation assessments.
- Experience using KNEAT/eVal.
Responsibilities
- Manage validation needs and deliverables for ongoing Validation activities as assigned to specialist.
- Work closely with IPT management to ensure safe, on-time, and correct execution of validation activities.
- Interface with site Validation SMEs to ensure validation practices are aligned with our Company network.
- Support site IPTs during investigations and troubleshooting.
- Support all aspects of the Continuous Validation Program
- Prepare, review, approve and execute validation documentation (including but not limited to; protocols, periodic assessments, and final reports) related to new or existing manufacturing projects to ensure successful completion is in alignment with West Point validation requirements.
- Train other Validation personnel (when required)
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
