Sr. Engineer
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Lead complex projects and drive the technical roadmap by developing equipment performance metrics, optimizing maintenance strategies, and implementing improvements to reduce downtime. Serve as the Subject Matter Expert for systems design, maintenance, and compliance operations, directly supporting troubleshooting, deviation processes, and CAPA implementation while ensuring Environmental, Health, and Safety standards. Collaborate with Engineering Staff and cross-functional departments to define requirements for large-scale system modifications, manage project budgets, and coordinate external consultants. Mentor top-tier talent and supervise a small staff of engineers and technicians on an ongoing basis.
Required Qualifications
- Master's degree in Engineering and 2 years of Engineering experience OR Bachelor's degree in Engineering & 4 years of Engineering experience
- 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
- 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 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
- Ability to handle multiple projects at one time
- Ability to collaborate with Engineering Staff
- SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations
- Support equipment troubleshooting within the functional area or in the scope of technical expertise
- Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise
- Drives Environmental, Health and Safety compliance within the organization
Desired Qualifications
- Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements
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