What are the responsibilities and job description for the Process Validation Engineer position at Stark Pharma Solutions Inc?
Job Title: Process Validation Engineer
Location: Birmingham, AL
Experience: 3 - 5 Years
Duration: 12 months
Overview
We're looking for a Process Validation Engineer with hands-on experience in aseptic pharmaceutical environments. The role focuses on equipment qualification, facility validation, and computerized system validation activities to support ongoing operations and regulatory compliance.
Responsibilities
Aseptic Facility and Equipment Validation
Location: Birmingham, AL
Experience: 3 - 5 Years
Duration: 12 months
Overview
We're looking for a Process Validation Engineer with hands-on experience in aseptic pharmaceutical environments. The role focuses on equipment qualification, facility validation, and computerized system validation activities to support ongoing operations and regulatory compliance.
Responsibilities
Aseptic Facility and Equipment Validation
- Develop URS, System Impact Control (SIC), and System Risk Assessments (SRA) for aseptic facilities and equipment.
- Prepare and execute Commissioning (COM) and Installation Qualification (IQ) protocols.
- Perform Operational Qualification (OQ) and Performance Qualification (PQ) activities.
- Ensure all validation documentation meets regulatory, industry, and internal quality standards.
- Conduct risk assessments and implement appropriate mitigation strategies.
- Support qualifications for systems such as homogenizers, pump skids, SIP/CIP skids, temperature control units, tanks, and CTU requalification.
- Develop and implement validation plans for computerized systems.
- Perform risk assessments with focus on data integrity and system performance.
- Create and maintain validation documentation, including system overviews, classifications, test scripts, and reports.
- Execute CSV protocols to verify system functionality and compliance.
- Bachelor's degree in Engineering or a relevant Science discipline.
- 3 - 5 Years of experience in validation or qualification of aseptic pharmaceutical processes, equipment, or systems.
- Strong working knowledge of FDA and EU regulations, industry best practices, and GMP requirements.
- Proficient in using Kaye Validator AVS, ValProbe systems, and standard office software.
- Experience with equipment qualification activities for homogenizers, pump skids, SIP/CIP skids, temperature control units, tanks, and CTU requalification.
- Strong communication, organization, and problem-solving abilities.