Senior Process Engineer – Pharma/Biotech

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

CIS International LLC in Juncos, PR is seeking an experienced engineer to independently characterize and direct optimization strategies for operations, manufacturing, or capital projects. You will apply advanced engineering principles to major system modifications and present results for complex issues.

The role includes supervising a small team, developing design documents, coordinating with multiple departments, and ensuring compliance with cGMP.

Qualifications

• Experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment.
• Preparation, review, and approval of technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Evaluation of equipment failures, performance, 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.

Responsibilities

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff 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.
• Application of mature engineering knowledge in planning and conducting projects.
• Other functions may be assigned.

Skills

Pharma processes

Validation familiarity

Regulated environment

Laboratory equipment operation

GLPs/GMPs

Education

Bachelors in Engineering + 4 years of Engineering experience.

Job description

CIS International LLC in Juncos, PR is seeking an experienced engineer to independently characterize and direct optimization strategies for operations, manufacturing, or capital projects. You will apply advanced engineering principles to major system modifications and present results for complex issues.

The role includes supervising a small team, developing design documents, coordinating with multiple departments, and ensuring compliance with cGMP.