Sr Engineer
On-site · Juncos, Juncos, Puerto Rico
Job Summary
Sr Engineer role focused on independent or directive characterization of process optimization strategies and troubleshooting across operations, manufacturing, pilot plant or capital projects. Applies advanced engineering principles to design and implement major system modifications, experiments, and projects; develops and presents results for issues or projects of significant scope. Requires strong knowledge of aseptic processing environments, PQ/NPI qualification activities, cGxP/regulatory guidance, validation protocol execution (URS/DS, IQ/OQ/PQ), SDLC, data integrity, FAT/SAT, and the ability to work extended hours; bilingual English/Spanish; proficient with Windows and MS Office.
Required Qualifications
- Engineer with years of 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)
- Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries
- Experience in direct process / manufacturing areas
- Must be fully bilingual (English / Spanish) with excellent oral skills
- Must be proficient using MS Windows and Microsoft Office applications
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
- Available to work extended hours, possibility of weekends and holidays
- Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience. Preferred: Mechanical or Chemical Engineering
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