Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, We are looking for Validation Quality Engineer for Medical Devices sector for the regions of Dorado, Puerto Rico.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Minimum 3+ years of experience in Quality Engineering or Validation (OQ/PQ/TMV/IPM) within an FDA-regulated manufacturing environment.
- Hands-on experience within the Validation lifecycle and required documentation documentation.
- Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
- Experience with data analysis tools and document management systems (e.g., Windchill preferred)
- Strong analytical & technical documentation skills, including verbal communication skills in Spanish and English.
Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. No C2C available.
Experience:
- Validation : 3 years (Required)
Language:
- Spanish and English (Required)
Work Location: In person
