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Entry Level Engineer
Caguas, Puerto RicoDescription
Searching for Engineers with professional experience or Intern/Coop experience in the pharmaceutical, Medical Devices or biotechnology industries. The candidate must have knowledge in GMP and regulatory environment.
Duties and Responsibilities
Education
Bachelor in Engineering
Ultimate Solutions Corp is an Equal Opportunity Employer.
Searching for Engineers with professional experience or Intern/Coop experience in the pharmaceutical, Medical Devices or biotechnology industries. The candidate must have knowledge in GMP and regulatory environment.
Duties and Responsibilities
- 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 Coop or Intern experience in a regulated industry.
- Programming skills are a plus.
- Strong problem-solving skills.
- Sense of urgency and attention to detail.
- Willingness to work overtime, including weekends, depending on business needs.
- Ability to work with minimal or no supervision.
- Strong interpersonal skills and ability to work effectively in a team environment.
- Fully bilingual (English and Spanish).
- Demonstrates intellectual curiosity, initiative, and a continuous improvement mindset.
- Proactive, adaptable, and eager to learn in a fast-paced environment.
Education
Bachelor in Engineering
Ultimate Solutions Corp is an Equal Opportunity Employer.