Validation Engineer Supply Chain Contract 24009

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.

The ideal candidate will have experience:

i) with validation/mapping of temperature controlled units (Refrigerators freezer warehouses etc.

ii) with authoring validation study protocols/ reports and basically a strong technical writer.

iii) with managing quality records such as deviations investigation reports CAPAs. etc.

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 rightfirsttime (RFT) completion and ontime 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 ontime 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 SOPs 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

BusinessMinded Leader (Proficient) Change Enabler (Proficient) Creative and Impactful Thinker (Proficient) Functional and Technical Expert (Proficient) Planner Organizer and Executor (Proficient) Trusted Partner (Proficient).

$4555/hr

This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated 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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