Sr Engineer
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Characterize process optimization strategies and troubleshoot operational issues in manufacturing, pilot plant, or capital projects environments. Design and implement major system modifications while developing engineering policies that affect multiple organizational units. Supervise and coordinate work for a small staff of engineers, associates, and technicians on both ongoing and project-based assignments. Apply advanced engineering techniques to develop technical solutions for complex problems involving aseptic processing, fill/finish operations, and New Product Introductions. Collaborate with research, manufacturing, and quality assurance departments to determine methodologies for large-scale system modifications and manage project budgets within schedule and quality constraints.
Required Qualifications
- Doctorate or Master's degree
- Bachelor's degree in Engineering
- 2 years of Engineering experience
- 4 years of Engineering experience
- 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
- Ability to develop solutions to routine technical problems of limited scope
- Comprehensive understanding of validation protocol execution requirements
- Established expertise in at least 3 separate areas of engineering technology
- Ability to independently determine when additional internal resources are required to solve problems
- Ability to handle multiple projects at one time
- 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
- Management of contractors and vendors
- Demonstrated Skills in problem solving and applied engineering
- Demonstrated Skills in basic technical report writing
- Demonstrated Skills in verbal communication
- Demonstrated Skills in basic technical presentations
- Demonstrated Skills in personal organization
- Demonstrated Skills in validation protocol writing
- Demonstrated Skills in dealing with and managing change
- Demonstrated Skills in technical (equipment specific)
- Demonstrated Skills in analytical problem solving
- Demonstrated Skills in computer literacy
- Demonstrated Skills in schedule development
- Demonstrated Skills in facilitation
- Demonstrated Skills in collaboration
- Demonstrated Skills in basic project management
- Demonstrated Skills in completion and follow-up
- Demonstrated Skills in negotiation, persuasion and facilitation
- Demonstrated Skills in conflict resolution
- Demonstrated Skills in leadership and teambuilding
- Demonstrated Skills in project cost development
- Engineer with experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines
Desired Qualifications
- Experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines
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