Validation Specialist

Job Title: Validation Specialist

Location: REMOTE (prefers Boston, MA)

Pay Range: $40-44/hour (long term contract)

Required Skills & Experience

1. High sense of urgency with the ability to multitask and understand how to pivot and reprioritize as business needs

2. GMP and GDP understanding manufacturing and documentation, excellent documentation practices

3. Validation experience- climate controlled practice

4. Experience with Operational Qualification (OQ), and Performance Qualification (PQ).

5. Technical writing- reports, protocols, etc.

Job Description

The Logistics (Shipping) Validation Engineer / Specialist will be responsible for overseeing and supporting the creation and management of logistics related validation records such as Operational Qualification (OQ), Performance Qualification (PQ) documents as well as support closure of quality records such as Change Controls, Deviations, CAPAs and Action Items related to Logistics Validation within the electronic quality record management system. The Engineer Specialist is a key resource within Logistics Validation team managing multiple studies and quality records within eQMS and ensure closure of the quality records by the agreed timelines. The Specialist coordinates or executes activities on multiple studies and takes the lead in managing the timelines and ensuring the completeness / technical merit of quality records in alignment with regulatory expectations.

Key Duties and Responsibilities:

• Support validation studies (Protocols, study executions, reports) required as part of new product launches and lifecycle management.

• Support deviations to achieve right-first-time (RFT) completion and on-time phase completion, including deviation closure by the defined due date.

• Ensure smooth transition of defined CAPA to the owning department SME and timely implementation to ensure on-time deviation closure.

• Utilize both soft skills and technical skills to drive the deviation and CAPA processes effectively, including teamwork, collaboration, communication, technical writing, and vendor coordination.

• Interface with Quality, Process Development, Regulatory, MSAT, Commercial and other Supply Chain Teams

• Support other supply chain validation related projects as needed.

• Strong foundation and demonstrated experience in:

o Proactive communication to ensure deadlines are met and no quality record goes overdue

o Basic understanding of GMP / GDP, as it relates to electronic recordkeeping o Basic understanding of Supply Chain Logistics

o Experience authoring and using GxP documents such as SOP’s and work instructions.

o Understanding of Validation Concepts and experience in conducting validation studies in a regulated environment.

o Excellent organizational skills

o B.S in scientific or allied health field o Typically requires 4 years of experience or the equivalent combination of education and experience.