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Validation Engineer

Posted 26 days ago

  • Sector: Engineering
  • Contact: Michael Menzer
  • Contact Email:
  • Contact Phone: (732) 353-4231
  • Start Date: 05/31/2021
  • Job Ref: 21-08502
Job Summary:

The Validation Engineer is critical to ensure that manufacturing, packaging and utilities equipment is maintained in a state of compliance. Authors and executes Installation and Operational Qualification Protocols to ensure equipment is properly qualified and suitable for use.

Essential Functions:
  • Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.
  • Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.
  • Author IQ/OQ protocols for new or used equipment purchased
  • Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.
  • Coordinate with manufacturing department to complete re-qualification activities with minimal impact to production schedule.
  • Write/revise Standard Operating Procedures (SOPs), protocols and maintenance reports for manufacturing and utility equipment.
  • Initiate Change Controls for Engineering Department activities and ensure their timely closure.
  • Process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT.
  • Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements.
  • Assist Engineering staff to troubleshoot equipment or facility problems and report them to supervisor.
  • Read and interpret equipment manuals, schematics and work orders to perform required maintenance and service.
  • Assist with maintenance compliance duties.
  • Assist the supervisor in compiling SITE MASTER PLAN and other relevant documents associated with inspection readiness
  • All other job-related duties.

Specialized Skills and Knowledge:
  • Bachelor's Degree in Engineering or related discipline
  • 3+ years' experience authoring and executing Equipment QualificationProtocols in the Pharmaceutical industry.
  • Experience with Computer Systems Validation/21 CFR Part 11
  • Proficient in Microsoft Office Suite (Word, Excel, Outlook)
  • Strong interpersonal communications skilled with excellent technical writing abilities
  • Demonstrated application of Good Engineering Practices on projects
  • Possess in-depth knowledge of GMP and regulations

Key Competencies:

1. Analytical Thinking/Problem Solving
2. Collaboration/Team Work
3. Multitasking/Good Communication Skills