Sr Engineer

QRC Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico seeks a Senior Engineer to support manufacturing equipment and systems within a regulated pharmaceutical/biotechnology environment. You will independently manage technical assessments, CAPA actions, and equipment improvement initiatives.

Responsibilities include system owner assessments, CAPA investigations, and applying lessons learned across equipment and processes. You will coordinate with Manufacturing, Quality and suppliers, and oversee Maximo work orders

Qualifications

• Lead system owner assessments and engineering impact assessments.
• Support technical investigations and CAPA actions.
• Evaluate CAPA applicability to other areas.
• Manage Maximo work orders and maintenance coordination.
• Develop preventive maintenance plans and SOPs.
• Support equipment troubleshooting and modernization projects.
• Work with bio-pharma equipment like centrifuges, autoclaves, process tanks, chromatography and UF/DF systems.
• Prepare technical reports with traceable documentation.
• Coordinate with Manufacturing, Quality, and suppliers.
• Manage multiple assignments with safety, quality, and operational priorities.

Responsibilities

• Perform system owner assessments and engineering impact assessments related to equipment failures and quality events.
• Support technical investigations, identify failure mechanisms, and develop CAPA actions to reduce recurrence.
• Evaluate applicability of CAPA and lessons learned to other equipment and areas.
• Manage engineering activities in IBM Maximo, including work orders and maintenance coordination.
• Develop and revise preventive maintenance strategies, Job Plans, SOPs.
• Coordinate with cross-functional teams to ensure timely actions and closure.

Skills

CAPA compliance

Maximo

Root cause analysis

Maintenance planning

Investigations

Cross-functional coordination

Education

Doctorate or Masters + 2 years

Bachelor's in Engineering + 4 years

Tools

None

Job description

Juncos, Puerto Rico

Sr Engineer with experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment, with the ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.

• Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
  
• Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
  
• Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
  
• Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
  
• Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
  
• Implementing engineering controls and completing actions associated with safety incidents and INCA records.
  
• Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
  
• Working with bio pharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizes, filter integrity testers, and associated instrumentation.
  
• Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
  
• Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
  
• Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs..
  

Requirements

• Doctorate or Masters + 2 years of Engineering experience or
  Bachelors in Engineering + 4 years of Engineering experience (Chemical, Mechanical or Electrical Engineer)