Process Engineer II

Medial Group; Villalba (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico, seeks a seasoned engineer to provide technical and sustaining support for utilities and regulatory systems in a GMP manufacturing setting. You will contribute to equipment qualification, commissioning, and process improvements to meet quality targets and production efficiency.

The role requires at least five years in utilities equipment and validation, a technical degree, and bilingual English/Spanish.

Qualifications

• Minimum 5 years of experience in utilities equipment, regulatory and compliance systems.
• Experience with validation phases (IQ/OQ/PQ) and commissioning.
• Bilingual (English and Spanish) and willing to work 100% on-site in Villalba.

Responsibilities

• Provide technical and sustaining engineering support for utilities systems in a GMP-regulated manufacturing environment.
• Lead validation activities for utilities (IQ, OQ, PQ) and ensure regulatory compliance.
• Develop and qualify processes and equipment to meet specifications and improve quality and efficiency.

Skills

Utilities validation

Regulatory compliance

Troubleshooting

SAP systems

GMP familiarity

Bilingual (English/Spanish)

Education

Bachelor's or Technical degree in Science or Engineering

Job description

villalba, Puerto Rico | Posted on 04/04/2025

Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

Other duties may be assigned.

• Responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards.
• This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air and HVAC.
  
• The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations.
• Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Requirements

Minimum 5 years of experience inUtilities Equipment, Regulatory and Compliance Systems, Troubleshooting, Agile Systems, SAP Systems,Validation Qualification Phases and Commissioning. Bachelor or Technical Degree in Science or Engineering. Bilingual. Willing to work 100% on-site in Villalba.

What are the top 3 things you are looking for in a candidates experience:

• 1. Validation of facilities and utilities equipment including air compressor and HVAC system
• 2. FDA and ISO regulated industry experience
• 3. Operational SOP, validation protocols and maintenance plan