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:
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Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
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Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
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Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
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Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
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Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
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Develop engineering policies and procedures that affect multiple organizational units.
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Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
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Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
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Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
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Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Qualifications:
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Bachelor’s degree in Engineering Required.
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Proven experience performing technical assessments of equipment in a regulated pharmaceutical, biotechnology, or manufacturing environment.
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Experience preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.
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Demonstrated ability to evaluate equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to product quality, processes, equipment qualification status, and intended use.
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Experience providing technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitment activities.
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Knowledge of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
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Ability to review and interpret engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
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Strong technical writing skills, with the ability to develop clear, factual, scientifically sound, and evidence-based conclusions and recommendations.
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Experience collaborating cross-functionally with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to gather and evaluate technical information.
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Working knowledge of cGMP requirements and the ability to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.
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Strong analytical, problem-solving, organizational, and communication skills.
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Ability to independently manage multiple technical assessments, priorities, and deliverables while meeting established timelines.
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Experience with purification systems, fermentation equipment, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
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Strong field presence and willingness to inspect equipment, interact with manufacturing personnel, and verify actual operating conditions within manufacturing areas.
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Ability to work effectively in a highly regulated environment and maintain a high level of attention to detail and documentation quality.
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Administrative Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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