Apply to Sr. Engineer- 35953

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.
Bachelor degree in Engineering, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
Process, equipment, device, and/or packaging knowledge is considered a strong plus.

PREFERRED QUALIFICATIONS:

The position is intended to primarily support manufacturing/process engineering activities, system configuration, and support (including DME and PLM), CPV activities, controlled documentation, and manufacturing process monitoring.
The candidate should have good analytical skills to evaluate manufacturing/process data and identify trends, but we are not looking for expertise in statistical modeling, machine learning, or advanced programming. Tools such as Excel, JMP, and Power BI would support the role rather than define it.
I would therefore recommend keeping the Sr Engineer title and revising the preferred qualifications to better reflect this focus. I provide an updated version of the qualifications for the posting below.
Preferred Candidate Profile

Education / Background

Bachelor’s degree in Engineering preferred, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
Knowledge of manufacturing processes, equipment, devices, packaging, and/or process operations is considered a strong plus.

Technical Skills

Experience supporting manufacturing process and operations in a GxP/GMP environment, with a solid understanding of process performance, equipment, and manufacturing workflows.
Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
Experience supporting controlled document and process changes, including document updates, coordination of reviews and approvals, implementation activities, and associated GMP documentation.
Experience supporting Continuous Process Verification (CPV) activities, including process data review, evaluation of process performance and variability, identification of trends, preparation of periodic CPV reports and presentations, and escalation of potential process performance issues.
Ability to interpret manufacturing and process data to support process monitoring, investigations, troubleshooting, and continuous improvement activities.
Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
Ability to perform system configuration activities, including understanding business and process requirements, evaluating configuration needs, implementing, or supporting configuration changes, testing changes, documenting results, and troubleshooting system or process issues.
Experience working with controlled documentation, data integrity requirements, and GMP systems, and change management processes.
Familiarity with SQL for data querying, troubleshooting, data verification, and investigation of system or process-related issues is preferred.
Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities is considered a plus.
Familiarity with tools such as Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies is considered a plus.
Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations, is preferred.
Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities is considered a strong plus.
General Skills
Strong engineering, analytical and technical problem-solving skills, with the ability to evaluate manufacturing, process and system issues and identify practical solutions.
Excellent written and verbal communication skills, with the ability to interact effectively across different communication and working styles.
Fully bilingual in English and Spanish.

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: 6 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: December 2026