Validation Engineer (Biorepository Services)

Blue Delta Technologies•Hopedale, MA

3d•$80,000 - $95,000•Onsite

About The Position

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.

Requirements

Strong knowledge of GMP/GLP, ICH stability guidelines, awareness of ISBER sample management guidelines and equipment validation processes.
Experience with environmental monitoring and data logging systems.
Must be physically present on site, proximity and availability to be on-call for temperature and equipment excursions, ability to operate autonomously and manage competing priorities under time pressure.
High attention to detail and strong documentation skills.
Effective communicator with excellent customer service skills

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.
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.
Ensure all activities comply with ICH Q1A, GxP, MHRA, FDA, and customer audit expectations.
Participate in internal and external audits.
Support change control, CAPA, and deviation processes.
Contribute to risk assessments related to sample handling, equipment failures, and OOC events.
Support capacity management and chamber utilization tracking.
Participate in disaster recovery planning, including backup equipment and sample relocation.
Provide input on continuous improvement initiatives for efficiency and compliance.
Follow biosafety, GxP, and H&S protocols in all work activities.
Handle hazardous substances safely where applicable.
Escalate OOC (out of condition) events immediately in line with SOPs.
Ensure safe working practices are maintained at all times.