Sr. Engineer- 34636

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.

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

• Masters 2 years of Engineering experience.
• Bachelors in Engineering 4 years of Engineering experience.
• Chemical or Mechanical Engineering

• GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation.
• Validation expertise: Experience in drafting executing and approving validation.
• Time pressure filling: Hands-on experience with time pressure filling systems.
• Technical documentation: Experience in preparing reviewing and approving protocols reports and strategy presentations.
• Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes.
• Communication skills: Strong written and verbal communication in English and Spanish.
• Collaboration: Proven experience working with QA Manufacturing and Engineering teams during critical activities.
• Shift flexibility: Willing and able to support non-standard shifts including nights weekends and extended hours.

1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope

• Problem solving and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.

• Basic technical presentations o Personal Organization o Validation Protocol Writing.
• Dealing with and managing change o Technical (Equipment Specific).
• Analytical Problem Solving o 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 o Facilitation
• Collaboration
• Basic project management o 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
• Project cost development
• Conflict Resolution
• Leadership and teambuilding
• Management of contractors and vendors

Work Methodology:

• 100% On-site
• 12 months (1st Contract)
• Administrative Shift(weekends and overtime may also be required).
• Professional Service Contract