Technical Source is seeking an experienced Automation Validation Engineer for our leading pharmaceutical manufacturing client in Marion, NC. The ideal candidate will have a strong background in automation systems, validation processes, and GMP environments, with a focus on ensuring the reliability and compliance of automated systems in pharmaceutical production.
Responsibilities of the Automation Validation Engineer include:
Automation System Validation: Develop, execute, and document validation protocols (IQ/OQ/PQ) for automated systems, ensuring compliance with GMP regulations.
System Troubleshooting and Support: Provide technical support for automation systems, diagnosing and resolving issues to maintain efficient and compliant operations.
Change Control Management: Oversee and manage change controls related to automation systems, ensuring thorough documentation and impact assessments.
Compliance and Quality Assurance: Ensure all automation systems meet regulatory requirements, working closely with quality assurance teams to maintain high standards of compliance.
Project Management: Lead automation validation projects, coordinating with cross-functional teams to ensure successful implementation and validation of new systems or upgrades.
Continuous Improvement: Identify opportunities for process and system improvements, implementing changes to enhance efficiency and compliance.
Qualifications of the Automation Validation Engineer include:
Bachelor's degree or higher in Engineering, Computer Science, or a related field.
3+ years of experience in automation validation within the pharmaceutical or biotech industry.
Proficiency in GMP regulations and guidelines related to automation systems.
Experience with validation protocols (IQ/OQ/PQ) and change control processes.
Strong analytical and problem-solving skills with the ability to troubleshoot complex systems.
Excellent communication and project management skills.
Compensation for the Automation Validation Engineer includes:
Salary: $80,000-$120,000 based on experience and qualifications.
Benefits: Comprehensive package including medical, dental, and vision coverage.
Note: No Corp to Corp or Visa sponsorships currently.