Equipment Validation Specialist

2 weeks ago


Summit, New Jersey, United States LanceSoft, Inc. Full time

Position: Equipment Commissioning & Qualification Engineer

Company: LanceSoft, Inc.

Overview:

The Equipment Commissioning & Qualification Engineer plays a crucial role in ensuring the effective implementation of laboratory equipment across multi-use sites. This position involves collaboration with both internal stakeholders and external service providers to facilitate the commissioning and qualification of new equipment, facilities, and utilities.

Key Responsibilities:

  • Support the commissioning and qualification processes for laboratory equipment, ensuring compliance with established policies and procedures.
  • Participate in projects and routine activities of varying complexity, contributing to the overall success of the team.
  • Conduct routine tasks with minimal supervision, utilizing analytical skills to identify and resolve common issues.
  • Engage with team members and supervisors to foster collaborative relationships and achieve shared objectives.

Essential Qualifications:

  • Bachelor's degree in Engineering or a related scientific discipline.
  • A minimum of 5 years of experience in a GMP environment, with at least 3 years focused on equipment, facility, or utility qualification.
  • In-depth knowledge of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11.
  • Experience in qualifying cell therapy equipment is advantageous.
  • Strong written and verbal communication skills, with the ability to interact effectively with a diverse workforce.
  • Proficient in Microsoft Office Suite and capable of learning new software systems quickly.

Core Competencies:

  • Ability to manage multiple tasks in a fast-paced environment while maintaining organizational efficiency.
  • Strong interpersonal skills and a commitment to building trust within the team.
  • Capability to develop qualification protocols and related documentation, ensuring adherence to change management processes.

Responsibilities Include:

  • Maintaining qualified equipment systems in alignment with company policies and guidelines.
  • Executing equipment qualifications and validation protocols while supervising vendor activities.
  • Creating written procedures for calibration and preventive maintenance of equipment.
  • Developing comprehensive validation and qualification deliverables, including Validation Plans and Summary Reports.


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