Pharmaceutical Manufacturing Specialist - Engineering Background

February 11

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Pharmavise Corporation

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Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

FDA Compliance Consulting • Project Management • Auditing • External Supply Operations • Quality Systems Management

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 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.

🎯 Requirements

• 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.