Manufacturing Systems Engineer - II

Validation Specialist – Computer Systems & Manufacturing Equipment
Location: West Point, PA (100% Onsite)

We are looking for a detail-oriented Validation Specialist to join the team at the West Point site. This role focuses on the periodic review of laboratory computer systems and manufacturing equipment to ensure continued compliance and performance. You will be responsible for the full lifecycle of the review process, from physical onsite inspections to the generation of technical summary reports.

Primary Responsibilities

• Periodic Reviews: Manage the review schedule and execute periodic reviews for both lab systems and manufacturing equipment.
• Compliance Oversight: Review Software Development Lifecycle (SDLC) documentation to ensure all systems meet internal Merck procedures and regulatory standards.
• Onsite Inspections: Conduct "walk-downs" of laboratory spaces to physically inspect equipment and systems in their operational environment.
• Data & Log Analysis: Review system events, logs, and issues identified during the review period to assess system performance and security.
• Maintenance & Calibration: Confirm that all calibration and maintenance actions are up to date and evaluate completed change records.
• Master Data Support: Assist in the implementation of a new computerized maintenance management system by reviewing and evaluating maintenance master data.
• Reporting: Analyze all collected data and author comprehensive reports summarizing findings, conclusions, and necessary actions.

Candidate Requirements

• Bachelor’s Degree in Engineering, Science, or a related technical field.
• Minimum of 2 years of experience within the Pharmaceutical industry.

Required Skills (Must Haves)

• Validation Knowledge: Solid understanding of computer system validation (CSV) processes and the Software Development Lifecycle (SDLC).
• Regulatory Awareness: Experience working within a cGxP / GMP or highly regulated environment.
• Technical Writing: Strong ability to synthesize technical data into clear, concise, and compliant reports.
• Physical Activity: Ability to move around the site, inspect lab systems, and perform physical equipment "walk-downs."
• Communication: Effective organizational and interpersonal skills to lead meetings with system owners and business stakeholders.

Preferred Qualifications

• Experience with Kneat (paperless electronic validation system).
• Familiarity with pharmaceutical manufacturing equipment and large-scale systems.
• Ability to work independently and facilitate tasks across multiple business areas.

Role Notes

• This is a fully onsite role requiring routine movement throughout the West Point facility.
• You will be expected to interface directly with lab owners and stakeholders to gather information and lead the review process successfully.