Validation Engineer III

Location: On-site Plainsboro Facility
Openings: 1

• Software qualification experience (specifically for calibration software)
• Equipment/process qualification experience
• Preferred: Experience with temperature mapping using KAYE validator probes

Qualified candidates must be experienced in one or more of the following areas of validation:

• Equipment Qualification
• Process Qualification

Responsibilities are directly associated with the introduction and launch of new equipment, products, or processes into a manufacturing facility. The candidate must:

• Utilize problem-solving techniques to resolve issues and meet organizational goals
• Be well-organized and technically sound in scientific rationale and quantitative justification
• Understand medical device process flow, regulatory impact of change, and compliant documentation
• Possess technical writing experience in protocol and procedure generation
• Have experience in master plan generation and change control lifecycle
• Be a team player with the ability to work independently
• Gown qualification is a plus, with knowledge of clean room practices and cGMP environments
• Understand risk management and identify/classify critical parameters in production

Direct supervision from Manager, Quality Engineering

None

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Generate and execute qualification/validation protocols, including summary documentation
• Generate and execute software qualification documentation (risk assessment, data integrity checks, trace matrices)
• Collaborate with project teams to develop DOEs and statistically sound tests
• Complete test method validation, gauge R&R studies, and other supporting qualifications
• Coordinate scheduling, material allocation, and personnel alignment for validation tasks
• Develop statistically based sampling plans for in-process and final test sequencing
• Ensure compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable standards
• Support and address comments on validation and engineering documentation
• Generate and approve protocols, deviations, and summary reports

• Bachelor s Degree in Engineering (Biomedical, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry)
• 4 to 7 years of experience in Validation or Quality Assurance in a medical device or pharmaceutical environment
• Excellent organizational and communication skills
• Experience qualifying medical device manufacturing equipment
• Results-oriented with strong quality principles and conflict resolution skills
• Strong technical writing skills and understanding of good documentation practices
• Experience with temperature mapping equipment (Kaye Validators and Valprobes)
• Competent in tracking and updating schedules for management visibility