Engineer Senior

Validation & Engineering Group; Juncos (PR); On-site; USD 110,000 - 180,000; Full time

Job summary

Validation & Engineering Group is a leading services supplier for the pharmaceutical, biotech, chemical, and medical devices industries. The role involves independent characterization of process optimization strategies, troubleshooting operations, and applying engineering principles to major system modifications.

Responsibilities include developing engineering policies, supervising a small team, and coordinating with project managers to meet schedule and budget constraints in regulated

Qualifications

• Doctorate or Master's degree with relevant engineering experience; alternatively a Bachelor's with substantial engineering experience.
• Familiarity with pharmaceutical/biotech processes and validation in a regulated environment.
• Ability to lead complex engineering projects, write technical documents and develop standards.

Responsibilities

• Develop and implement engineering policies and procedures across multiple units.
• Supervise and coordinate engineers, associates and technicians on projects.
• Apply advanced engineering techniques to complex system modifications and capital projects.
• Collaborate with research, manufacturing, process development and QA to define design requirements.
• Develop budgets for projects and ensure timely, on-budget delivery.
• Lead design documents and coordinate consultants and external firms.

Skills

Engineering leadership

Project management

Validation processes

GLPs GMPs knowledge

Communication

Education

Doctorate degree

Master’s degree + 3 years experience

Bachelor’s degree + 5 years experience

Tools

Process simulation software

Job description

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

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

• 1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• 2. Develop engineering policies and procedures that affect multiple organizational units.
• 3. 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.
• 4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• 5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• 6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• 7. Application of mature engineering knowledge in planning and conducting projects.

* Other functions may be assigned

Design Engineering

• 1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• 2. 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.
• 3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• 4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• 5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

EDUCATION

Doctorate degree or Master’s degree and 3 years of Engineering experience or Bachelor’s degree in Engineering and 5 years of Engineering experience.

PREFERRED 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
• 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

Qualifications

Doctorate degree OR

• Master’s degree and 3 years of Engineering experience OR
• Bachelor’s degree in Engineering and 5 years of Engineering experience.

• Industrial Eng, Mechanical Eng, Electrical Eng, Biochemical Eng and Chemical Engineering
• Knowledge in protein purification and hands on experience supporting the manufacture of a biological drug substance
• Basic understanding of protein purification and filtration techniques, as well as its associated equipment: chromatography, ultrafiltration, normal flow filtration, etc.
• Process development experience supporting cGMP commercial-scale operations
• Strong capability for scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills
• Ability to write technical documents, develop and execute detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Ability to adapt in a dynamic environment
• Excellent written and verbal communication

Additional Information

All your information will be kept confidential according to EEO guidelines.