Pharmaceutical Manufacturing Specialist – Engineering Background

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Pharmavise Corporation

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2013

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation est la première organisation de conformité continue (CCO) dédiée au maintien des normes les plus élevées de qualité et de conformité réglementaire dans l'industrie des sciences de la vie. Notre prestigieuse clientèle comprend des entreprises du Fortune 500 dans les secteurs pharmaceutiques, des dispositifs médicaux et de la biotechnologie. Nous offrons des solutions sur mesure adaptées aux besoins spécifiques de conformité de nos clients, les soutenant du développement à la commercialisation et veillant à ce qu'ils dépassent leurs objectifs de conformité tout en améliorant la santé et la sécurité des patients.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• Competitive compensation packages are available