Validation Engineers

Validation Engineers at Vidlexinfo LLC

Analyze validation test data to determine whether systems or processes meet validation criteria and identify root causes of problems for pharmaceutical and related facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate, and maintain databases for tracking validation activities, test results, and validated systems.

Apply Lean Manufacturing, Six Sigma, Gage R&R, and Minitab methodologies. Conduct First Article Inspection Reports (FAIR), Capability Studies, and Risk Assessments. Perform Root Cause Analysis (RCA) and Process Development & Troubleshooting. Utilize Design of Experiments (DOE), Aseptic Processing, and adhere to Standard Operating Procedures (SOPs). Ensure compliance with GMP, cGMP, ISO 13485, and ISO 14971 standards. Manage Change Control processes and participate in Material Review Board (MRB) activities.

Close Nonconformance Reports (NCR) and Nonconformance Material Reports (NCMR). Implement Kaizen and Statistical Process Control (SPC). Conduct Test Method Validation (TMV) and Fault Tree Analysis. Utilize AutoCAD and Solid Works for design and validation tasks.

Positions requires Masters Degree in Health Informatics, Pharmacy, Science, Engg. (any field) or related. Jobs based in Nutley, NJ. No travel (US or Intl), but 40% chance of relocation to unanticipated locations throughout the U.S. Email resume to i or mail to Vidlexinfo LLC, 510 Franklin Avenue, Suite 4, Nutley, NJ 07110.

Entry level

Full‑time

Quality Assurance

IT Services and IT Consulting

Nutley, NJ