Apply to 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:

Preferred candidate should have experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment. Experience should include:

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: 13 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: August 2026