Validation Specialist Engineering

Job Description

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. When required the Validation Specialist will also be required to train other Validation personnel.

• 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.

• BS, Preferably in Engineering or Sciences.
• Minimum of 2 years of relevant work experience, hands‑on experience on validation activities on sterile product 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.).

• Experience working on cross‑functional team to achieve common goal.
• Experience writing validation assessments.
• Experience using KNEAT/eVal.

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

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring tween process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights. EE incluye GINA Supplement. Learn more about your rights, including under California, Colorado and other US State Acts.

Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions;

facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position…