Senior Validation Engineer

6 days ago

Rensselaer, United States Novozen Healthcare LLC Full time

Job Title: Equipment Commissioning and Qualification Specialist

Location: Onsite, 5 days/week, Rensselaer, NY

Duration: 1+ year

About the Role:

Our client is seeking a skilled Equipment Commissioning and Qualification Specialist to oversee the seamless setup, validation, and qualification of critical equipment. This role is essential to maintaining high standards of quality and compliance within the facility. The ideal candidate has a robust background in IQ/OQ/PQ processes, fill-finish manufacturing, videography, and automated visual inspection (AVI), with a particular focus on leading smoke study initiatives for large equipment.

Essential Skills & Experience:

  • Smoke Studies Expertise: Extensive experience with smoke studies for large equipment, including program design, protocol writing, and execution.
  • Automated Visual Inspection (AVI): Knowledge of AVI systems and processes, with experience in setup, validation, and troubleshooting.
  • Videography: Skilled in creating video documentation for operational and validation processes.
  • Fill Line Operations: Proven experience working with fill lines in a manufacturing environment.
  • Clean Room and Equipment Qualification: Proficient in clean room qualification, equipment qualification (IQ, OQ, PQ), and utilities/cleaning processes.
  • Protocol Management: Strong abilities in writing, executing, and managing qualification protocols.

Key Responsibilities:

  1. Commissioning & Qualification: Lead IQ, OQ, and PQ processes for large equipment, ensuring compliance with regulatory standards and internal protocols.
  2. Fill-Finish Operations: Oversee fill-finish processes to uphold product quality and Good Manufacturing Practices (GMP).
  3. Automated Visual Inspection (AVI): Implement and validate AVI systems for quality control, ensuring effective inspection and troubleshooting.
  4. Videography for Documentation: Develop high-quality video resources to document equipment setup, operations, and validations for training, audits, and internal use.
  5. Smoke Study Program Development: Establish and execute a smoke study program to assess airflow and particle distribution, ensuring regulatory compliance and identifying areas for improvement.
  6. Cross-Functional Collaboration: Work closely with quality assurance, engineering, and operations teams to document, communicate, and execute qualification processes effectively.

Additional Qualities:

  • Strong collaboration and team-working skills
  • Eagerness to learn and adapt
  • Ability to take direction effectively

This position is ideal for someone experienced in equipment qualification, clean room standards, fill-finish operations, and AVI systems who seeks to make an impact in a high-quality, regulated environment.

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