Facilities & Engineering Quality Systems Specialist

ProQuality Network; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network is seeking a Facilities & Engineering Quality Systems Specialist to support GMP quality systems within a pharmaceutical manufacturing environment. You will partner with Facilities & Engineering and Quality teams to manage deviations, CAPAs, change controls, and controlled documentation.

The role emphasizes hands-on work across engineering, quality, and regulatory functions, ensuring inspection-ready records and effective electronic forms.

Qualifications

• Bachelor's, Master's, or Doctorate in Engineering or related technical field with 2+ years of pharmaceutical experience.
• Strong knowledge of Quality Systems: Deviations, CAPA management, Change Controls, and controlled documentation.
• Experience in the pharmaceutical manufacturing industry and regulatory compliance.
• Understanding of pest control programs within a regulated environment.
• Excellent organizational, communication, and problem-solving skills.

Responsibilities

• Provide primary support for Quality Systems activities related to Facilities & Engineering.
• Investigate and document deviations from procedures, specs, or requirements per SOPs.
• Partner with stakeholders to develop, monitor, and close CAPAs on time.
• Ensure records are complete, accurate, compliant, and inspection-ready.
• Support electronic forms and workflows for quality and facilities systems.
• Assist with pest control program management and related documentation.

Skills

Quality Systems

Deviations

CAPA management

Change Controls

Controlled documentation

Pest control program

Facilities engineering

GMP compliance

Education

Bachelor's degree in Engineering or related field

Master's degree

Doctorate degree

Tools

Electronic forms systems

Quality management software

Job description

Our client is seeking a Facilities & Engineering Quality Systems Specialist to support the integrity, compliance, and continuous improvement of manufacturing facilities and engineering systems within a pharmaceutical manufacturing environment.

This role will serve as a key partner to Facilities & Engineering (F&E), Quality, and cross-functional teams, providing hands-on support for Quality Systems activities including deviations, CAPAs, Change Controls, controlled documentation, electronic quality/facilities forms, and pest control program management.

The ideal candidate combines a strong understanding of engineering or facilities operations with practical experience in GMP Quality Systems and regulatory compliance. This is an excellent opportunity for a detail-oriented professional who enjoys working across technical, quality, and operational functions.

Key Responsibilities

Our client is seeking a Facilities & Engineering Quality Systems Specialist to support the integrity, compliance, and continuous improvement of manufacturing facilities and engineering systems within a pharmaceutical manufacturing environment.

This role will serve as a key partner to Facilities & Engineering (F&E), Quality, and cross-functional teams, providing hands-on support for Quality Systems activities including deviations, CAPAs, Change Controls, controlled documentation, electronic quality/facilities forms, and pest control program management.

The ideal candidate combines a strong understanding of engineering or facilities operations with practical experience in GMP Quality Systems and regulatory compliance. This is an excellent opportunity for a detail-oriented professional who enjoys working across technical, quality, and operational functions.

Key Responsibilities

Quality Systems & Compliance

• Provide primary support for Quality Systems activities related to Facilities & Engineering, including deviations, CAPAs, Change Controls, and controlled documentation.
• Investigate and document deviations from established procedures, specifications, or requirements in accordance with applicable SOPs.
• Partner with Quality and cross-functional stakeholders to develop, implement, monitor, and close effective CAPAs on time.
• Ensure Quality Systems records are complete, accurate, compliant, and maintained in an inspection-ready state.

Electronic Quality & Facilities Systems

• Support the creation, completion, review, routing, and tracking of electronic forms and/or similar electronic quality and facilities-management systems.
• Ensure electronic forms and associated records are accurate, complete, properly maintained, and processed within required timelines.
• Collaborate with Facilities & Engineering, Quality, and other stakeholders to resolve questions or issues related to electronic forms and workflows.

Pest Control Program

• Support the enhancement and continuous improvement of the site's pest control program.
• Coordinate with external pest control vendors and internal stakeholders to address and resolve pest control issues.
• Support program documentation, records, and follow-up activities to ensure compliance with applicable requirements.

Qualifications & Experience

• Bachelor's, Master's, or Doctorate degree in Engineering or a related technical field with 2+ years of experience in the pharmaceutical industry.

• Strong knowledge and demonstrated experience with Quality Systems, particularly: Deviations, CAPA management, Change Controls, and Controlled documentation.
• Experience working in the pharmaceutical manufacturing industry.
• Understanding of pest control programs within a regulated manufacturing environment.
• Knowledge of FDA requirements and other applicable regulatory requirements.
• Strong organizational, communication, and problem-solving skills.
• Highly detail-oriented, with a strong focus on quality, compliance, accuracy, and timely execution.