Engineering Specialist (Validation)

Medial Group; Puerto Rico; On-site; USD 70,000 - 100,000; Full time

Job summary

Medial Group in Puerto Rico is seeking a detail-oriented professional to support evaluation, qualification, and documentation of computerized systems and manufacturing processes in FDA-regulated environments.

You will prepare and execute validation protocols, develop IQ documentation, and collaborate with process owners to implement changes while ensuring compliance. Strong bilingual communication in English and Spanish is required.

Qualifications

• Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience.
• Practical knowledge and demonstrated competence in validation and quality systems.

Responsibilities

• Evaluate impact of validated computerized systems on work instructions.
• Prepare and execute computer system validation protocols and generate comprehensive reports.
• Develop and maintain Installation Qualification (IQ) documentation.
• Collaborate with process owners to implement changes to work instructions and ensure compliance.
• Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
• Ensure adherence to company procedures, quality system regulations, and industry standards.
• Apply technical expertise to optimize equipment and manufacturing techniques.
• Organize and track project progress, maintaining detailed documentation and status updates.
• Contribute to cross-functional projects and support milestone completion.
• Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.

Skills

Process validation

Computerized systems validation

Bilingual English/Spanish

Education

Advanced degree

Job description

Support the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.

Responsibilities may include the following and other duties may be assigned:

Evaluate the impact of validated computerized systems on existing work instructions and processes.

Prepare and execute computer system validation protocols and generate comprehensive reports.

Develop and maintain Installation Qualification (IQ) documentation.

Collaborate with process owners to implement changes to work instructions and ensure compliance.

Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.

Ensure adherence to company procedures, quality system regulations, and industry standards.

Apply technical expertise and knowledge of Medtronic's engineering practices to optimize equipment and manufacturing techniques.

Organize and track project progress, maintaining detailed documentation and status updates.

Contribute to cross-functional projects and support milestone completion.

Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.

Requirements

• Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
• Practical knowledge and demonstrated competence in validation and quality systems

Top 3 Qualifications:

Hands-on experience in Process and Computerized Systems Validation

Background in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)

Excellent verbal and written communication skills in both English and Spanish

*Willing to work 100% On-Site in Villalba. *