Validation Engineer (Biorepository Services)

Job Description

Job Description

Description :

Stability Storage Technician & Validation Engineer (Sample Management & Equipment Servicing)

Hopedale, MA (onsite requirement)

Salary : $80-$95k (FT, Full Benefits)

The individual will act as a key point of contact and site representative for customers within the service portfolio of biorepository services and stability storage. They must have excellent communication skills, be highly organized, a strong team player, and capable of working to tight deadlines. They will work closely with the sales representatives to manage customer relationships and are expected to optimize operational delivery and suggest initiatives that improve quality, turnaround times, and cost efficiency.

Summary :

The overall objective is to deliver, either independently or as part of a team, stability storage and biorepository services to customers and manage facility needs and on site equipment. The role includes managing sample pulls in line with customer protocols, servicing and validating equipment, and ensuring activities comply with relevant SOPs, GxP standards, and regulatory guidelines (MHRA, FDA, ICH). The post-holder is responsible for maintaining the integrity of customer products at all times and contributing to a safe, efficient, and compliant operating environment.

Job Function / Responsibilities :

Sample Management

• Pull, prepare, and document customer samples according to customer protocols and internal SOPs. - Maintain accurate chain of custody records and ensure timely dispatch of samples. - Coordinate with QA and customers on study schedules. - Manage retained and returned samples according to disposal or return policies.
• Equipment Servicing & Validation
• Conduct daily / weekly / monthly checks on equipment, logging data as per SOPs. - Perform routine servicing, e.g., filter changes, defrosting, alarm testing, calibration verification. - Escalate issues requiring engineering support or supplier intervention.
• Plan and execute IQ, OQ, and PQ of new and existing stability units. - Maintain validation schedules, calibration certificates, and deviation logs.

Quality & Compliance

Skills & Attributes :

Requirements :