Sr. Engineer 33071 - 1828625

Exciting Opportunity: Senior Engineer 33071 (Pharma/Biotech Industry)

Location: Juncos, PR (Onshore, 100% Onsite, 2nd and 3rd shifts)

Positions: 2

Educational/Software Requirements:

Doctorate degree OR Master's degree and 3 years of Engineering experience OR Bachelor's degree in Engineering and 5 years of Engineering experience.

Summary:

Independently provide and/or direct the characterization of process optimization strategies and troubleshoot operational issues in the operations, manufacturing, pilot plant, or capital projects environment. Apply advanced engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects. Develop, organize, analyze, and present interpretations of results for operational issues or engineering projects of significant scope and complexity.

Preferred Qualifications:

Experience in Parenteral Inspection and/or Packaging equipment.

Knowledge in Engineering Project.

Experience in Medical Device or Pharma.

Knowledge in CAPA, Change Management, and Compliance.

Skills and Qualifications:

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.

Problem-solving and applied engineering.

Basic technical report writing and verbal communication.

Comprehensive understanding of validation protocol execution requirements.

Basic technical presentations and personal organization.

Validation Protocol Writing and dealing with managing change.

Technical (Equipment Specific) and analytical problem-solving.

Computer Literacy and specialized equipment/process expertise.

In-depth knowledge of validation processes and requirements as applied to new equipment installations.

Interacts effectively with a 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, and 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 and project cost development.

Conflict Resolution, leadership, and teambuilding.

Management of contractors and vendors.

Functions:

Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.

Develop engineering policies and procedures affecting 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 within the area of engineering expertise.

Apply knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.

Serve 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 the development of standard design documents.

Develop departmental budgets or project budgets encompassing multiple disciplines for an area within a project or the entirety of a smaller project.

Join us in shaping the future of Pharma/Biotech Engineering!