2 Validation Engineer IV Jobs in Abbott, TX
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Validation Engineer IV
$106k-121k (estimate)
Contractor
3 Weeks Ago
Katalyst Healthcares & Life Sciences is Hiring a Validation Engineer IV Near Abbott, TX
Responsibilities
- Maintaining the integrity of the client Quality System
- Act as a single point-of-contact to interface with Client division customers
- Develop and manage documentation for engineering studies ( "ES). Execute ES activities.
- Develop and manage documentation for commissioning tests ( "CT). Execute CT activities as required.
- Develop and maintain the validation traceability matrix ( "VTM)
- Provide data entry and statistical analysis of data collected during validation activities.
- Develop documentation for GMP criticality assessment and coordinate activities.
- Interprets validation/user requirements, provides validation strategy in conjunction with division quality and operations organizations, develops and drafts validation protocols [i.e. Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ),] executes validations and documents validation results in final reports
- Ensures that validations are documented using Good Documentation Practices and in compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Client Policies and Procedure
- Perform and document investigations related to validation activities and performs risk assessments of equipment and processes to support scope of validation.
- Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance.
- Provide quality-related discipline expertise to divisional customers, project teams and consultation to direct and contingent project personnel.
- Performs other duties as assigned by Management.
- 5-10 years of related work experience in a medical device or other healthcare industry with strong technical competency in performing facility/utilities/equipment qualification, et al. validations
- Must be familiar with good documentation practices (GDP) and cGMP environment.
- Strong validation experience in the following areas: Facilities (Clean rooms, HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Statistical Sampling and Process Monitoring (SPC
- Has a history of completing successful cross-functional projects and driving positive, compliance outcomes.
- Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence.
- Experience in temperature/humidity mapping studies and validation of facilities storage spaces and manufacturing rooms, as well as environmental equipment (e.g., Freezers, Refrigerators, Humidity Chambers, Incubators, etc.)
- Experience with troubleshooting and commissioning of commercial and/or industrial refrigeration systems, HVAC units, utilities distribution and controls (multiple platforms is a plus)
Job Summary
JOB TYPE
Contractor
SALARY
$106k-121k (estimate)
POST DATE
06/01/2024
EXPIRATION DATE
07/20/2024
WEBSITE
katalysthls.com
HEADQUARTERS
South Plainfield, NJ
SIZE
<25
Related Companies
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The job skills required for Validation Engineer IV include Validation Protocols, Risk Assessment, Installation, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer IV. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer IV. Select any job title you are interested in and start to search job requirements.
For the skill of Validation Protocols
Katalyst Healthcares & Life Sciences
Contractor
$106k-121k (estimate)
3 Weeks Ago
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