About the role
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: * Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization, upgrades, replacements, and equipment modifications. * Serve as a technical resource for equipment, processes, and systems during troubleshooting and cross-functional discussions. * Monitor manufacturing processes and equipment performance, identify operational issues, and recommend solutions. * Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams on process and system improvements. * Support deviations, equipment qualification, process validation, procedures, training, and New Product Introduction activities. * Analyze operational data and present findings and recommendations for engineering projects and manufacturing issues. * Apply engineering principles to system modifications, experiments, equipment improvements, and capital projects. * Support design and construction projects, including reviewing technical documents, equipment quotes, project schedules, and cost estimates. * Evaluate and resolve technical problems using analytical and troubleshooting skills while working under general supervision. * Ensure manufacturing activities comply with corporate policies, industry standards, GMP/GLP requirements, and applicable regulatory expectations. * Provide engineering support for 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.
Qualifications: * Bachelor’s degree in Engineering (Chemical Engineering Preferred) * Statistical Analyses experience * Experience in Biotech companies would be a plus * Drug substance manufacturing/technical support would be a plus * 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. * Strong troubleshooting and problem-solving skills related to purification processes. * 1st and Administrative Shift