QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environmentApplies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimizationFunction as a technical expert to equipment or systems regarding troubleshooting operationsFrequently become actively involved in daily operations when required to meet schedules or to resolve complex problemsRoutinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexityWork with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modificationsWork under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraintsWork with consultants, architects and engineering firms on development of standard design documentsObtain and critique quotes for equipment modifications or installationsGenerate rudimentary project cost estimates and schedulesQualifications:
Bachelor's degree in engineering (Chemical Engineering, Mechanical Engineering, and Industrial engineering fields)2 years of Engineering experienceGeneral packaging/engineering experience in final product manufacturing within the Pharma/Biotech IndustryExcellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.
)Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standardsStrong interpersonal, project management, technical problem solving and communication (written and verbal) skillsAbility to work in teams and adapt to a continuously evolving environmentAbility and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging componentsAvailable for administrative Shift (8am to 5pm)
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