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Validation Specialist
Job Location:
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
5years
Experience Required:
Posted:
10 October 2026 (2 days ago)
Posted:
Application Deadline:
7 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Validation Specialist with a strong knowledge of injection molding processes to support the development execution and documentation of validation activities (Protocols Tests Reports).
- Familiarized with IQ OQ and PQ validation phases for molds and equipment.
- IQ: Confirmation of Drawings (including mold attributes) Equipment and Procedures (mold setup and operating) mechanical assessment of mold and equipment.
- Develop inspection programs and instructions for setup/positioning of tooling and parts.
- Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
- Updating and defining Standard Operating Procedures (SOPs).
- Familiarized with Gage R&R methodology preferable.
- Preferably familiarized with metrology equipment and methods such as calipers micrometers CMM Programmable Vision Inspections Systems.
Requirements
- Bachelor in Science
- Experience in FDA regulated industry
- 5 years of experience performing validation lifecycle activities
- Technical writing skills
- Read write speak and understand English and Spanish
Required Skills:
Validation
Required Education:
Bachelors degree in Life Sciences
