Validation Engineer

Birmingham, AL, US • Posted 60+ days ago • Updated 6 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

URS
IQ
OQ
PQ
Presentation Software
SIP
Risk Assessment
Data Integrity
Documentation
Test Scripts
Regulatory Compliance
Computerized System Validation
Conflict Resolution
Problem Solving
Critical Thinking
Communication
Manufacturing
Science
Pharmaceutics

Summary

Responsibilities:

Develop URS, SIC and SRA for new and existing aseptic facilities and equipment.
Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications.
Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions.
Ensure all documentation is compliant with regulatory requirements and internal quality standards.
Conduct risk assessments and implement mitigation strategies for aseptic processes.
bility to work closely and effectively with other workgroups to successfully complete projects on time and thoroughly.
Work independently or within a team environment.
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company.
Proficient in the use of word processing, spreadsheet, and presentation software programs. Proficient in use if Kaye Validator AVS and Val Probe Systems.
Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units Tanks, Requalification of CTU's.
Develop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal policies.
Conduct risk assessments to identify potential issues related to system functionality and data integrity.
Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate compliance with regulatory requirements.
Execute CSV protocol, to verify that systems function as intended.
Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity.
Excellent interpersonal skills.
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company.
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes.
bility to work closely and effectively with other workgroups to successfully complete projects on time and thoroughly.

Requirements:

Bachelor's degree preferably in Engineering or Science discipline.
3 - 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment.
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 42a69f9c43f476cc8ed32b642d6b8140
Posted 30+ days ago

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