Pharmaceutical / Biotechnology Engineer – Multiple Specialties

ProQuality Network; Dorado (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

ProQuality Network is seeking on-site Engineering professionals in the East region of Puerto Rico to support pharmaceutical and medical device projects. Candidates will be matched to assignments based on background in process, equipment, reliability, validation, commissioning, and technical assessments.

We value candidates with 2+ years of engineering experience in regulated manufacturing environments and the ability to collaborate across Manufacturing, Quality, and Validation teams.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, Chemical, Biomedical, or related).
• 2+ years of engineering experience in pharmaceutical, biotechnology, biopharmaceutical, or other highly regulated manufacturing environment.
• Candidates with specialized experience in process engineering, equipment engineering, reliability, validation/qualification, commissioning/decommissioning, or technical assessments are encouraged to apply.

Responsibilities

• Lead engineering and equipment improvement projects and collaborate with Manufacturing, Operations, Quality, Validation, and Facilities.
• Provide technical vendor management, risk assessments, and documentation.
• Support deviations, investigations, CAPAs, change controls, and GMP documentation.
• Assist in commissioning/decommissioning, IQ/OQ/PQ, and validation activities.
• Write technical reports and maintain project documentation.

Skills

Process engineering

Bioprocess engineering

Equipment engineering

Reliability engineering

Technical assessments

Project coordination

Education

Bachelor's degree in Engineering

Tools

CMMS

GxP documentation

Job description

ProQuality Network is seeking Engineering professionals to provide services to our clients in the pharmaceutical and medical device industries.Candidates may be considered for assignments based on their specific engineering background and area of expertise, including:

Process & Bioprocess Engineering

• Biopharmaceutical and biotechnology manufacturing processes
• Purification operations, chromatography, and UF/DF
• Process optimization and troubleshooting
• Fermentation and process equipment
• Manufacturing, pilot plant, and capital projects

Equipment & Reliability Engineering

• Manufacturing equipment ownership and lifecycle management
• Equipment reliability, availability, and downtime reduction
• Preventive maintenance and maintenance strategy optimization
• CMMS, work orders, spare parts, and equipment performance metrics
• Equipment troubleshooting and improvement projects
• Reliability and change control assessments

Technical Assessments & Engineering Support

• Equipment evaluations, technical assessments, and engineering reports
• Equipment failure and performance investigations
• Evaluation of maintenance history, operating conditions, and equipment reliability
• Technical justifications and fitness-for-intended-use assessments
• Review of engineering drawings, specifications, vendor documentation, manuals, calibration records, and historical data
• Technical support for deviations, investigations, CAPAs, change controls, and risk assessments
• Commissioning and decommissioning of equipment and systems
• Equipment qualification and validation
• IQ/OQ/PQ and validation protocols
• Impact assessments and risk assessments
• GMP documentation and Good Documentation Practices (GDP)
• Asset lifecycle management and regulatory compliance

Manufacturing & Inspection Equipment

• Automated and manual inspection equipment
• Inspection technologies for parenteral products and glass containers
• Equipment modifications and system improvements
• Manufacturing systems, utilities, facilities, and automation
• Equipment performance and reliability improvement

Project & Cross-Functional Engineering

• Engineering and equipment improvement projects
• Collaboration with Manufacturing, Operations, Maintenance, Quality, Validation, Automation, Process Development, Facilities, and Utilities
• Technical vendor management and stakeholder coordination
• Technical writing, documentation, and project management

Education & Experience

• Bachelor's degree in Engineering ( Mechanical, Electrical, Industrial, Chemical, Biomedical, or related engineering backgrounds).
• 2+ years of engineering experience in pharmaceutical, biotechnology, biopharmaceutical, or another highly regulated manufacturing environment.
• Candidates with specialized experience in process engineering, equipment engineering, reliability, validation/qualification, commissioning/decommissioning, or technical assessments are encouraged to apply.

Candidate must be able to work on-site in the East region of Puerto Rico (Gurabo-Canovanas region).