About Avispa Technology
Sourced by ZipRecruiter
Company size
51 - 200 Employees
Headquarters location
San Carlos, CA, US
Year founded
2011
$42/hr
Full-time
Medical, Dental, Vision, Life, Retirement
Posted 15 days ago
Job description
Validation Engineer ROCGJP00040514
- Hourly pay: $42/hr
- Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite)
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program
- 40 hours/week, 12 Month Assignment
A leading biotechnology company is seeking a Validation Engineer ROCGJP00040514 to support process validation activities in a regulated manufacturing environment. This role will focus on ensuring compliance, supporting operational integrity, and driving continuous improvement initiatives within FDA-regulated operations.
Validation Engineer ROCGJP00040514 Responsibilities:
- Develop, review, and execute process validation and process verification protocols, reports, and supporting documentation for new and existing manufacturing processes.
- Conduct risk assessments, analyze validation data, and ensure compliance with FDA, ISO, cGMP, and internal quality and regulatory requirements.
- Collaborate cross-functionally with Manufacturing, Quality, and Design Transfer Operations teams to resolve validation issues, implement corrective actions, and support process optimization initiatives.
- Maintain validation documentation and traceability for audits and inspections while providing training and guidance to manufacturing and quality personnel on validation procedures and best practices.
- Support continuous improvement efforts and additional validation or quality-related projects as assigned by management.
Validation Engineer ROCGJP00040514 Qualifications:
- 1-3 years of experience in a regulated manufacturing environment, such as medical devices, pharmaceutical, or biotech industries, is preferred.
- Bachelor's Degree in Engineering or Life Science.
- Strong understanding of process validation principles, methodologies, and industry standards.
- Knowledge of cGMP, FDA, ISO, and related regulatory requirements.
- Strong technical writing, analytical, troubleshooting, and problem-solving skills.
avispatechnology.com
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Validation Engineer?
A: To succeed as a Validation Engineer, key technical skills include proficiency in regulatory frameworks such as FDA and ISO 13485, as well as expertise in validation methodologies like risk-based validation and design control. Additionally, strong analytical and problem-solving skills, along with proficiency in programming languages like Python or SQL, are essential for developing and executing validation protocols. Soft skills such as effective communication, attention to detail, and a methodical approach to problem-solving also contribute to success in this role, enabling Validation Engineers to collaborate with cross-functional teams and ensure compliance with regulatory requirements.
Q: What is the career path for a Validation Engineer?
A: A Validation Engineer's career path typically begins with entry-level roles such as Validation Engineer or Junior Validation Specialist, where they gain hands-on experience in designing, implementing, and executing validation protocols for medical devices, pharmaceuticals, or other regulated products. As they progress to mid-level roles like Senior Validation Engineer or Validation Lead, they develop expertise in regulatory compliance, risk management, and team leadership, and may also take on responsibilities such as training and mentoring junior engineers. Senior Validation Engineers or Validation Managers often oversee large-scale validation projects, develop and implement validation strategies, and may also pursue certifications like CQE (Certified Quality Engineer) or CVA (Certified Validation Engineer) to further advance their careers.
