Pharmaceutical Manufacturing Specialist – Engineering Background

🕒 Abril 21

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Pharmavise Corporation

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2013

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation é a primeira Organização de Conformidade Contínua (CCO) dedicada a manter os mais altos padrões de qualidade e conformidade regulatória na indústria de ciências da vida. Nossa prestigiada base de clientes inclui empresas Fortune 500 nos setores farmacêutico, de dispositivos médicos e de biotecnologia. Oferecemos soluções sob medida para atender às necessidades específicas de conformidade de cada cliente, apoiando-os do desenvolvimento à comercialização e garantindo que superem suas metas de conformidade enquanto promovem a saúde e a segurança dos pacientes.

Descrição

• Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities. • Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations. • Lead or participate in process improvement initiatives, including the identification, evaluation, and implementation of new technologies, equipment, and manufacturing practices. • Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements. • Provide technical support for troubleshooting manufacturing issues, deviations, and investigations, and implement corrective and preventive actions (CAPAs) as needed. • Support the design, installation, qualification, and validation of manufacturing equipment and facilities, including process equipment, utilities, and cleanrooms. • Develop and maintain manufacturing documentation, including standard operating procedures (SOPs), batch records, and equipment qualification/validation documentation. • Stay abreast of industry trends, advancements, and regulatory requirements in pharmaceutical manufacturing and engineering, and apply best practices to drive continuous improvement.

🎯 Requisitos

• Bachelor's degree in engineering (chemical, mechanical, electrical, or related discipline) required; advanced degree preferred. • Minimum of 5 years of experience in pharmaceutical manufacturing or related industry, with a focus on engineering support for manufacturing operations. • Strong understanding of pharmaceutical manufacturing processes, equipment, and facilities, including solid dosage forms, liquids, and sterile products. • Experience with process improvement methodologies, such as Lean Six Sigma, and demonstrated ability to drive efficiency and quality improvements. • Knowledge of regulatory requirements and guidelines governing pharmaceutical manufacturing (e.g., cGMP, FDA, EMA) and experience with regulatory inspections and audits. • Proficiency in engineering software and tools for process simulation, equipment design, and data analysis. • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders. • Ability to work independently and manage multiple projects simultaneously, with a strong focus on results and attention to detail.

🏖️ Benefícios

• Competitive compensation packages are available