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Validation Specialist
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Validation Senior Specialist
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Insight Global Lansdale, United StatesOne of our large pharmaceutical clients is actively looking for a Validation Senior Specialist, specializing in Filter Validation, to join their team in West Point, PA. The Validation SME will be responsible for oversight of validation activities as part of the Bio-Sterile Valida ...
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Filter Validation Specialist
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Insight Global Lansdale, United StatesOne of our large pharmaceutical clients is actively looking for a Validation Senior Specialist, specializing in Filter Validation, to join their team in West Point, PA. The Validation SME will be responsible for oversight of validation activities as part of the Bio-Sterile Valida ...
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Validation - Validation Specialist
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Validation Specialist
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Charter Global Philadelphia, United StatesThe Client is one of the top 4 big firms in the USA. · Job Title: Instrument Validation Specialist · Duration: 6 months contract · Notes: · Looking for an Instrument Validation Specialist - need someone familiar with lab equipment, but the overall project will be for both pharmac ...
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Validation Specialist
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Validation Specialist
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PCi Corporation Philadelphia, United StatesRed Lion Road-PA002 · SUMMARY: · The main functions of a Validation Specialist are focused around the qualification of pharmaceutical packaging equipment and validation of the associated processes run on this equipment. These functions include generation and execution of protocol ...
Filter Validation Specialist - Lansdale, United States - Insight Global
Description
One of our large pharmaceutical clients is actively looking for a Validation Senior Specialist, specializing in Filter Validation, to join their team in West Point, PA.
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.
Required Skills and Experience
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 and Experience
Audit Experience
Equipment Manufacturing
Gamma Sterilization
Experience using KNEAT/eVal
This is a year extending contract, working 4 days onsite, 1 day REMOTE
Compensation :
$70/hr to $85/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.
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