Position: Validation Specialist
Type: Contractor
Location: [Specify Location]
Industry: Medical Devices
Overview:
We are seeking a dedicated and detail-oriented Validation Specialist to join our team as a contractor in the medical device industry. The ideal candidate will have experience in equipment and process validation, particularly with molding and laser equipment, and will possess strong troubleshooting skills. You will play a crucial role in ensuring that our equipment and processes comply with regulatory requirements and industry standards, supporting the production of high-quality medical devices.
Key Responsibilities:
- Plan, develop, and execute validation protocols (IQ/OQ/PQ) for equipment and processes, ensuring compliance with industry standards and regulatory guidelines.
- Focus on validation activities related to molding and laser equipment to ensure consistent, reliable performance.
- Provide expertise in troubleshooting and resolving technical issues with equipment, particularly related to molding and laser technologies.
- Work closely with maintenance and engineering teams to identify root causes and implement corrective actions for equipment issues.
- Develop and maintain validation documentation, including protocols, reports, and any relevant records.
- Ensure that validation documentation complies with Good Manufacturing Practices (GMP), FDA, and other relevant regulatory standards.
- Actively participate in process improvement initiatives to enhance equipment performance and process efficiency.
- Recommend and implement modifications to validation processes to optimize performance and compliance.
Qualifications:
- Bachelor's Degree in Engineering (Mechanical, Electrical, or related field).
- 2-5 years of experience in equipment and process validation, preferably in the medical device industry.
- Experience with molding and laser equipment is highly preferred.
- Proven ability in equipment troubleshooting and resolution of technical issues.
- Strong understanding of validation principles, including IQ, OQ, and PQ.
- Familiarity with Good Manufacturing Practices (GMP), FDA regulations, and other industry standards.
- Excellent written and verbal communication skills for effective documentation and cross-functional collaboration.
- Ability to work independently as well as part of a team in a fast-paced environment.
Our client is an equal-opportunity employer. We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.