Sr. Engineer- 35771

CiS International; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

CiS International in Juncos, PR is seeking a senior engineer to independently lead process optimization and troubleshooting in manufacturing and capital projects. You will apply advanced engineering principles to design and implement major system modifications and to analyze results for complex operational issues.

The role requires hands-on design, project supervision of a small team, and collaboration with QA, validation, utilities and facilities to meet schedule, budget and quality

Qualifications

• Pharma/biotech packaging experience preferred.
• Excellent understanding of GMP and GDP.
• Strong knowledge of testing standards (ASTM/ISO/TAPPI/USP/EP).
• Strong interpersonal, project management, and communication skills.

Responsibilities

• Complete complex assignments requiring new engineering techniques.
• Develop engineering policies affecting multiple units.
• Supervise and review work of a small staff of engineers/technicians.
• Apply advanced engineering techniques within area of expertise.
• Collaborate with QA, validation, utilities, facilities and manufacturing to implement system modifications.

Skills

Pharma/biotech processes

Validation protocols

GLPs and GMPs

Project management

Analytical problem solving

Communication skills

Education

Doctorate or Masters + 2 years of Engineering experience

Bachelors in Engineering + 4 years of Engineering experience

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:

1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. 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.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.

*Other functions may be assigned

Design Engineering:

1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. 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.
3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
5. 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:

1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. 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: 12 months for the first contract with a high possibility of extension based on performance and budget.
• Administrative Shift (weekends and overtime may also be required).
• Expected hiring date: October 2026