Sr Engineer - Juncos, PR - 35600

Integrated Services For Productivity & Validation, Inc; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a licensed engineer to perform technical assessments of pharmaceutical equipment in regulated manufacturing environments.

Responsibilities include preparing and reviewing technical reports, supporting deviations and CAPAs, evaluating equipment design and lifecycle, and collaborating with cross-functional teams to ensure evidence-based conclusions and compliance with cGMP.

Qualifications

• Bachelor's in Engineering required with 4+ years of engineering experience.
• Experience in regulated pharma/biotech manufacturing environments preferred.
• Strong technical writing, problem-solving and communication skills.

Responsibilities

• Perform technical assessments of equipment in regulated pharma/biotech manufacturing environments.
• Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Support deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
• Assess equipment design, functionality, reliability, lifecycle documentation, and maintenance strategies.
• Review engineering drawings, vendor documentation, and calibration records to support conclusions.
• Collaborate with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors.

Skills

Technical writing

Problem-solving

Communication

Field inspection

Education

Bachelor's in Engineering

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Juncos, Puerto Rico | Posted on 08/05/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

referred candidate should have experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment. Experience should include:

• Preparation, review, and approval of technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Evaluation of equipment failures, performance issues, maintenance history, operating conditions, and potential impact to product, process, quality, and equipment qualified state.
• Technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
• Assessment of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
• Review and interpretation of engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
• Development of clear, factual, and scientifically justified conclusions and recommendations based on available evidence.
• Experience collaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain and evaluate technical information.
• Knowledge of cGMP requirements and the ability to ensure that technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.
• Strong technical writing, problem-solving, and communication skills, with the ability to independently manage multiple assessments and deliverables.
• Experience with purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
• Strong field presence and willingness to inspect equipment and verify actual operating conditions within manufacturing areas.

Requirements

Bachelors in Engineering + 4 years of Engineering experience.