What are the responsibilities and job description for the Validation Engineer position at Accelerate Professional Talent Solutions?
We are seeking a skilled and driven Validation Engineer to join our dynamic team in a ISO:13485 certified medical device manufacturing facility. In this role, you will play a critical part in integrating custom products to meet customer needs, collaborating with Sales and Design Teams to ensure product designs align with manufacturing goals and customer expectations. You will be responsible for supporting the validation and commercialization of new products and processes while ensuring compliance with regulatory standards.
Key Responsibilities:
- Validation Protocol Development: Create and implement validation protocols (IQ, OQ, PQ) for new and existing manufacturing processes and equipment.
- Execution and Oversight: Lead and conduct validation activities to ensure processes meet defined specifications and regulatory requirements.
- Data Analysis: Analyze validation data to identify trends, deviations, and opportunities for improvement.
- Collaboration: Work cross-functionally with Engineering, Production, and Quality Assurance teams to facilitate successful validation efforts.
- Documentation: Prepare and review validation documentation, reports, and risk assessments, ensuring compliance with regulations.
- Regulatory Compliance: Ensure all validation activities adhere to FDA, ISO, and other relevant regulatory requirements.
- Training & Mentoring: Provide guidance and training to junior staff on validation practices.
- Continuous Improvement: Drive process improvements and maintain quality standards across multiple manufacturing sites.
Qualifications:
- Education: Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Experience: 3 years in validation engineering or quality assurance in a regulated manufacturing environment (medical device, pharmaceutical, or biotechnology).
- Technical Skills:
- Knowledge of validation methodologies and regulatory standards.
- Proficiency in statistical analysis and quality control techniques.
- Experience with validation software and tools.
Preferred Qualifications:
- Experience in contract manufacturing or medical products.
- Familiarity with Lean Manufacturing, Six Sigma, and FMEA.
- Project management experience.
- Experience in consumer product packaging and designing products with flexible films.
Soft Skills:
- Strong analytical and problem-solving abilities.
- Excellent communication skills (written and verbal).
- Ability to work collaboratively in a team-oriented environment.
- Willingness to travel to support integration activities across multiple sites.
If you're passionate about medical device manufacturing, process improvement, and ensuring products meet the highest quality standards, we encourage you to apply and become part of our growing team!
Salary : $65,000 - $80,000
