Sr Engineer

Ultimate Solutions Corp; Juncos (PR); On-site; USD 110,000 - 165,000; Full time

Job summary

Ultimate Solutions Corp. is a trusted provider of packaging automation, serialization and compliance for Life Science industries in Puerto Rico and Europe.

This role involves directing characterization of process optimization strategies and troubleshooting in operations, manufacturing, pilot plant or capital projects environments. Develops and applies engineering principles to major system modifications, analyzes results, and presents insights to support large projects.

Qualifications

• Engineer with experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
• 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 problem solving and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.
• 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
• Schedule development
• Facilitation
• Collaboration
• Project cost development
• Conflict Resolution
• Leadership and teambuilding
• Management of contractors and vendors

Responsibilities

• 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.
• 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.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Skills

Aseptic processing

Fill/Finish operations

Validation (PQ)

GLPs/GMPs

Documentation

Laboratory equipment

Engineering problem solving

Technical report writing

Verbal communication

Project coordination

Analytical thinking

Education

Doctorate or Master’s in Engineering

Bachelor’s in Engineering

Tools

Laboratory equipment

Documentation systems

Job description

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

Description

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

Education

Doctorate or Master’s degree and 2 years of Engineering experience or Bachelor’s degree in Engineering and 4 years of Engineering experience

Responsibilities

• 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.
• 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.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Requirements / Skills

• Engineer with experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
• 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

Ultimate Solutions Corp is an Equal Opportunity Employer