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 _ Specialist will also 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 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.).

• 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

Current Employees apply HERE

Current Contingent Workers apply HERE

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

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Merck & Co., Inc., Rahway, небольшой, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship sri:
No

Travel Requirements: 10%

Flexible Work Arrangements:
Hybrid

Shift: 1stforge Leon

Valid Driving License:
Yes

Hazardous Material(s): N/A

Job Posting End ngokup: 01/26/2026

* A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job…