Validation Specialist

Compensation:

$68/hr to $75/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

BS, Engineering or Sciences 7+ years' experience in Validation Expertise in Filter Validation Extractables & Leachables Equipment Sterilization Experience GMP Pharma Regulated Environment Experience Strong knowledge and hands on experience interpreting guidance/guidelines such as but not limited to; Annex 1, ISO, USP, PDA and AAMI for different leachable/extractable testing and Filter validation

Nice to Have Skills & Experience

Audit Experience Equipment Manufacturing Gamma Sterilization Experience using KNEAT/eVal

Job Description

One of our large pharmaceutical clients is actively looking for a Validation Senior Specialist, specializing in Filter Validation, to join their team. The Validation SME will be responsible for oversight of validation activities as part of the Bio-Sterile Validation SME Team. Main responsibilities include change control assessments for filters, leachable & extractables, & supporting Integrated Product Teams (IPTs) involved in vaccine manufacturing. The Senior Specialist SME will review and approve validation documentation (including but not limited to; validation strategies, detail design, user requirements document) related to new or existing manufacturing sterile projects to ensure successful completion is in alignment with validation requirements. Validation disciplines can range, but are not limited to Container Closure Integrity, Filter Assessments, Extractables and Leachables, Cleaning, Sterilization, or Controlled Temperature Units. Also, when required the Sr. Specialist SME will be required to train and coach junior engineer/specialist in the area of Validation. Additional Responsibilities include: - Responsible for defending site and company validation policies/practices in front of regulatory agencies during inspections and regulatory submissions. - Support new or existing product regulatory filing requirement and provide subject matter expertise review throughout the process. - Identify validation improvement initiatives for alignment with current validation best practices. - Generate and approve validation assessment for various processes - Interface with global validation group to ensure validation practices in west point are aligned with our Company network. - Complete gap assessments for our Company global guidance and perform remediation activities to ensure site compliance.- - Support site IPTs during investigations and troubleshooting as a Validation subject matter expert. - Provide support to obtain accurate and real time site validation metric to maintain the health validation compliance. - Identify validation improvement initiatives for alignment with current validation best practices. - Manage and Support aspects of the Continuous Validation Program This is a year extending contract, working 4 days onsite / 1 WFH.