Senior Process & Equipment Engineer - Pharma Manufacturing

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Quality Consulting Group, LLC is a leading provider to the pharmaceutical, biotech, medical devices, and manufacturing sectors. We seek a highly motivated engineer to join our team in Puerto Rico & USA, contributing to world-class manufacturing projects.

The role involves independent technical assessments, complex system modifications, and cross-functional collaboration with operations, QA, validation, and external vendors. Strong technical writing and budgeting skills are essential for success.

Qualifications

• Bachelor’s degree in Engineering is required.
• Experience performing technical assessments of equipment in regulated pharma/manufacturing environments.
• Experience preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Demonstrated ability to evaluate equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to product quality, processes, equipment qualification status, and intended use.
• Experience providing technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitment activities.
• Knowledge of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
• Ability to review and interpret engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
• Strong technical writing skills, with the ability to develop clear, factual, scientifically sound conclusions and recommendations.
• Experience collaborating cross-functionally with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to gather and evaluate technical information.
• Working knowledge of cGMP requirements and the ability to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.

Responsibilities

• Independently provides and/or directs the characterization of process optimization strategies and troubleshooting in operations, manufacturing, pilot plant or capital projects environments.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments on requirements and recommendations for large and/or complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.

Skills

Technical assessment

Technical writing

Cross-functional collaboration

Regulated environment knowledge

Problem solving

Project management

Equipment evaluation

Education

Bachelor’s degree in Engineering

Job description

Quality Consulting Group, LLC is a leading provider to the pharmaceutical, biotech, medical devices, and manufacturing sectors. We seek a highly motivated engineer to join our team in Puerto Rico & USA, contributing to world-class manufacturing projects.

The role involves independent technical assessments, complex system modifications, and cross-functional collaboration with operations, QA, validation, and external vendors. Strong technical writing and budgeting skills are essential for success.