Ultimate Solutions is a Global Leader in Validation, Serialization, Industrial Automation & Compliance for the Life Sciences Industries.
The Validation Specialist resource must have experience in the pharmaceutical or medical devices industries. The candidate must have solid GMP and regulatory experience with expertise in Validations.
Duties and Responsibilities
- Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis.
- Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
- Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
- Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Prepares and coordinate qualification activities.
- Communicate with the staff and management on ways of implementing plans and recommendations.
- Minimum of 2-5 years of relevant experience in Validations for packaging equipment preferably in medical device or pharmaceutical industry
- Experience in process validation IQ/OQ/PQ; protocols generation, execution, and reports. (Automatic assembly and packaging)
- Generation and approval of process documentation (e.g. SOP’s, etc.).
- Knowledge of Minitab
- Self-starter, dynamic person
- Fully Bilingual (English/Spanish – both oral and written)
- Knowledge of applicable US non-US applicable regulations
- Knowledge and proficiency in the application and principles of Validation
- Regulatory Documentation
Bachelor in Science or Engineering
Ultimate Solutions Corp is an Equal Opportunity Employer.