Hiring for a Validation Specialist in Groton, CT!

We are seeking a Validation Specialist to join our team for a new project involving the retrofitting of a clinical API manufacturing space to create a new milling suite. This role requires compiling information, writing specification documents, and executing protocols. The Validation Specialist will be responsible for writing installation qualification, operational qualification, and performance qualification protocols, as well as summary reports.

Responsibilities

• Retrofit an area in the clinical API manufacturing space to create a new milling suite. This includes reducing large particles of powder into smaller particles, with specific exposure requirements and controlled facility conditions such as differential pressures and air locks.
• Compile information, write specification documents, and execute protocols. This includes writing installation qualification, operational qualification, and performance qualification protocols, as well as summary reports.
• Install an isolator and milling equipment, ensuring the actual mill heads that pound the powder are placed inside the isolator.
• Collaborate with the facilities management engineering department for space modifications, process utilities for qualification, and the quality assurance organization for document review and approval.
• Report directly to the project lead and work independently, providing direction to other team members who assist with protocol execution.

Essential Skills

• Strong validation includes experience in writing and executing protocols and understanding the validation lifecycle.
• Experience with GMP documentation is crucial, as the role involves creating and managing detailed documentation in a regulated environment.
• At least five years of experience in validation engineering.
• Comfortable using Microsoft suite of products for document creation and management.
• Experience in a regulated environment, with a strong understanding of documentation and compliance requirements.

Additional Skills & Qualifications

• Familiarity with electronic document management systems.
• Experience in other regulated industries, such as submarine manufacturing, is acceptable if candidates are comfortable with documentation requirements.

Work Environment

The core business hours are from 7 AM to 4 PM, with flexibility for an 8 to 8.5-hour work period within that timeframe. The team typically starts early and finishes by around 3 PM. The position is primarily onsite, but there is potential for remote work depending on the individual's ability to manage their time effectively. Remote work is possible for tasks like documentation preparation.