Equipment Validation Specialist
2 weeks ago
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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