Pharmavise Corporation ยท 1 month ago
Pharmaceutical Manufacturing Specialists with Engineering Background
United States
Contract
Remote
Senior Level
5+ years expPharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. They are currently seeking a skilled Pharmaceutical Manufacturing Specialist with an engineering background to support manufacturing operations, optimize processes, and ensure compliance with regulatory requirements.
Food and BeverageHealth Care
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering (chemical, mechanical, electrical, or related discipline) required
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
Preferred
advanced degree preferred
Company
Pharmavise Corporation
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11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
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