Sr. Engineer- 35600 (CAPA & Investigation)

CIS International LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

CIS International LLC in Juncos, PR is seeking a Sr. Engineer- 35600 (CAPA & Investigation) to independently drive characterization, troubleshooting, and optimization across operations, manufacturing, pilot plant or capital projects.

The role applies advanced engineering to design and implement major system modifications and to analyze results for significant issues. The successful candidate will lead complex projects, write clear technical reports, and collaborate with Manufacturing, QA,

Qualifications

• Bachelor degree in engineering with relevant work experience in pharmaceutical environments.
• Experience preparing technical reports, assessments and justifications.
• Knowledge of cGMP requirements and ability to ensure traceable evidence.
• Strong written and verbal communication and ability to manage multiple assessments.

Responsibilities

• Lead complex engineering assignments and develop new methods and procedures.
• Develop policies affecting multiple units and supervise engineers and technicians.
• Coordinate with manufacturing, validation, QA and external vendors for data and design input.
• Inspect equipment in manufacturing areas to verify operating conditions.

Skills

Pharma/biotech processes

Validation & cGMP

Technical writing

Problem solving

Cross-functional collaboration

Engineering design & modification

Project supervision

FDA compliance support

Education

Bachelors in Engineering + 4 years of Engineering experience

Job description

Sr. Engineer- 35600 (CAPA & Investigation)

SUMMARY:
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

FUNCTIONS

General

• 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

Design Engineering

• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly 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

EDUCATION

• Bachelors in Engineering + 4 years of Engineering experience.

PREFERRED QUALIFICATIONS

• 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.

SKILLS

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.

Demonstrated skills in the following areas

• Problem solving and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.

Demonstrated Skills in the following areas

• Basic technical presentations
• Personal Organization
• Validation Protocol Writing
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Computer Literacy
• Specialized equipment/process expertise
• In-depth knowledge of validation processes and requirements as applied to new equipment installations.
• Interacts effectively with variety of communication and working styles.
• Ability to independently determine when additional internal resources are required to solve problems.
• Ability to handle multiple projects at one time.

Demonstrated Skills in the following areas

• Schedule development
• Facilitation
• Collaboration
• Basic project management
• Completion and follow-up
• Established expertise in at least 3 separate areas of engineering technology.
• Ability to independently determine when additional external resources are required to solve problems.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage the project work of others.

Demonstrated Skills in the following areas

• Negotiation, persuasion and facilitation
• Collaboration
• Project cost development
• Conflict Resolution
• Leadership and teambuilding
• Management of contractors and vendors.

WORK METHODOLOGY

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 13months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Expected hiring date: August 2026