Sr. Engineer- 35760

CIS International LLC; Juncos (PR); On-site; USD 95,000 - 160,000; Full time

Job summary

CIS International LLC in Juncos, PR seeks a senior engineer to lead complex process optimization and capital project initiatives in a regulated manufacturing environment. You will apply advanced engineering principles to design and implement major system modifications and analyze results for operational issues.

Responsibilities include supervising engineers and technicians, developing and enforcing design and validation documentation, and coordinating with manufacturing, QA, and utilities to

Qualifications

• Doctorate or Master's in Engineering with 2+ years of experience.
• Bachelor's in Engineering with 4+ years of experience.
• Pharma/biotech validation familiarity.
• Experience with GMP/GLP documentation.
• Ability to lead maintenance and reliability programs.

Responsibilities

• Develop and implement engineering strategies for major system modifications.
• Supervise engineers and technicians on projects.
• Coordinate with manufacturing, QA, and utilities to meet scope, schedule and budget.
• Lead reliability and maintenance improvements.

Skills

Pharma processes

Validation GMP/GLP

Problem solving

Maintenance planning

Education

PhD or MS in Engineering

Bachelors in Engineering

Tools

CMMS

Financial analysis tools

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 orMasters + 2 years of Engineering experience.
• Bachelors in Engineering + 4 years of Engineering experience.

PREFERRED QUALIFICATIONS

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
• Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization
• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
• Lead the implementation of equipment improvements projects
• SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
• Support equipment troubleshooting within the functional area or in the scope of technical expertise.
• Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization.

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 Organizationo 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: 7months for the first contractwith a high possibility of extension based on performance and budget.
• The shift is normally for the 1st shift (8 am to 5 pm) with the acknowledge that during executions of protocol or line support, the shift could be extended or adjusted to support this particular situations.
• Expected hiring date: October 2026