Job 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.
Benefits: