Offer summary

Qualifications:

B.S. in a scientific or allied health field., Typically requires 4 years of experience or equivalent education and experience., Strong understanding of GMP/GDP and supply chain logistics., Experience in authoring GxP documents and conducting validation studies..

Key responsabilities:

Oversee and manage logistics validation records including OQ and PQ documents.

Support validation studies for new product launches and lifecycle management.

Coordinate and execute activities on multiple studies, ensuring timely closure of quality records.

Interface with various teams to drive deviation and CAPA processes effectively.

Job description

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.

General Summary:

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:
- Proactive communication to ensure deadlines are met and no quality record goes overdue
- Basic understanding of GMP / GDP, as it relates to electronic recordkeeping
- Basic understanding of Supply Chain Logistics
- Experience authoring and using GxP documents such as SOP’s and work instructions.
- Understanding of Validation Concepts and experience in conducting validation studies in a regulated environment.
- Excellent organizational skills
- B.S in scientific or allied health field
- Typically requires 4 years of experience or the equivalent combination of education and experience.

Job Qualifications

Business-Minded Leader (Proficient), Change Enabler (Proficient), Creative and Impactful Thinker (Proficient), Functional and Technical Expert (Proficient), Planner, Organizer, and Executor (Proficient), Trusted Partner (Proficient).

Pay Range:

$45-55/hr

Requisition Disclaimer:

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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No C2C or Third-Party Vendors

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