Job Title: Engineer (Biotechnology) – 3369314Work Arrangement: 100% On-SiteLocation: East Area, Puerto RicoContract Type: Contract through ProQuality NetworkSummaryProQuality Network is seeking a highly motivated Engineer (Biotechnology) to support our client in the biopharmaceutical industry. This is a contract position where the selected candidate will represent ProQuality Network onsite, providing engineering support in operations, manufacturing, pilot plant environments, or capital projects. The Engineer will contribute to process optimization, equipment troubleshooting, and system modifications by applying sound engineering principles. This role will involve hands-on technical tasks, coordination with cross-functional teams, and execution of engineering projects of moderate complexity.
Candidates should be able to analyze data, present findings, and contribute to solutions in regulated environments. Key ResponsibilitiesGeneral Engineering FunctionsProvide solutions to moderately complex technical problems. Apply standard engineering techniques and procedures under general supervision. Investigate variables, analyze results, and complete assigned technical tasks. Initiate and complete routine technical assignments with minimal guidance. Operations EngineeringAct as a technical expert on specific equipment or systems to troubleshoot and optimize operations. Engage in day-to-day operations as needed to support production schedules or resolve complex issues. Routinely audit performance and regulatory compliance of assigned equipment and systems.
Collaborate with cross-functional teams (Manufacturing, Quality, Maintenance, Validation, etc. ) to recommend or implement system modifications. Design & Capital ProjectsSupport project managers in the design, engineering, and implementation of capital and system modification projects. Work closely with consultants, architects, and engineering firms to develop standard design documentation. Request and evaluate equipment quotes; develop basic project cost estimates and schedules. Required Education & Experience Bachelor's degree in Engineering and at least 2 years of engineering experience OR Master’s degree in Engineering (no experience required)Preferred QualificationsExperience in packaging or general engineering in pharmaceutical or biotech manufacturing environments. Strong knowledge of:
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)Pharmaceutical packaging components (bottles, labels, trays, lidding materials, etc. )Testing standards: ASTM D4169, ISO, TAPPI, USP, EPFamiliarity with validation protocols, regulatory documentation, and cleanroom operations. Ability to write and execute test protocols and technical evaluations for material and component validation. Experience collaborating in cross-functional teams in a dynamic, regulated environment. Working knowledge of pharmaceutical/biotech processes and validation documentation. Skilled in use of laboratory equipment and software systems as applicable.
Technical Skills & CompetenciesProblem solving and applied engineering techniquesTechnical report writing and protocol documentationUnderstanding of GLPs and GMPsFamiliarity with equipment qualification and validation executionTechnical presentation and verbal communicationOrganizational and time-management skillsChange management in regulated environmentsProficient in computer systems and data analysis toolsIf you are ready to take on a rewarding opportunity and represent ProQuality Network at a leading biopharma organization, please apply through the job description link with your most updated resume.
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