Sr. Engineer- 35771

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

Job summary

Cis-International-LLC in Juncos, PR seeks a senior design engineer to independently characterize and implement process optimization strategies across operations, manufacturing, pilot plants or capital projects. You will apply advanced engineering principles to major system modifications and present results for complex issues.

You will lead a small team, develop procedures, coordinate with QA, validation, utilities, and ensure GMP/GDP compliance with emphasis on validating new equipment and

Qualifications

• Deep knowledge of pharmaceutical/biotech manufacturing processes and compliance with GMP/GDP.
• Experience designing or modifying complex systems in pharma settings.
• Ability to write test protocols and perform technical evaluations.

Responsibilities

• Develop and apply advanced engineering techniques for major system modifications.
• Supervise and coordinate engineers/technicians on projects.
• Coordinate with project managers, consultants, architects and vendors on design documents.
• Prepare budgets for multi-discipline projects and ensure schedule adherence.

Skills

Pharma/biotech processes

Validation processes

GLPs & GMPs

Engineering problem solving

Team leadership

Project management

Technical communication

Adaptability in evolving environment

Education

Doctorate or Masters + 2 years experience

Bachelors in Engineering + 4 years experience

Tools

Laboratory equipment

Computers

Job description

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

• Doctorate or Masters + 2 years of Engineering experience.
• Bachelors in Engineering + 4 years of Engineering experience.

PREFERRED QUALIFICATIONS

• General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.
• Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).
• Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.
• Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.
• Ability to work in teams and adapt to a continuously evolving environment.
• Ability and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.

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.

• 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.

• 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.

• 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: 12months 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: October 2026