Entry Level Engineer

Ultimate Solutions • Caguas, PR

9h

About The Position

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.

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level