• 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
• 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

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 for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

$87,300.00 - $137,400.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation