Pharmaceutical Manufacturing Specialists with Engineering Background
Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking Pharmaceutical Manufacturing Specialists with an Engineering background to join its cadre of consultants. The specialist must have a strong GMP background and demonstrable hands-on experience and skills.
Key areas of expertise:
• All major pharmaceutical manufacturing processes for both simple and complex molecules; biopharmaceuticals a plus.
• Process and/or production engineering
• Deep knowledge of data and processes typically found within the manufacturing, utilities, facilities, maintenance, engineering and warehouse areas
• Computerized systems and IT technologies that support the manufacturing and related environments
• Auditing manufacturing systems and the entire lifecycle of product and related data
• Process mapping and design
• Compliance regulations including 21 CFR part 11 and global guidances for data integrity
• Familiarity with computer validation, equipment qualification, and process validation concepts and approaches
Key Skills:
• Translating detailed data integrity concepts and issues to concise and professional communications for mid- and upper-level management and framing the issues from the right perspective
• Translating regulatory compliance into pragmatic and practical business process and technology solution recommendations
• Analyzing data; Analytical mindset – ability to detect trends and patterns
• Working at all levels from manufacturing technician through upper management
• Conducting GMP audits of facilities and processes for global manufacturing of pharma products
• Making recommendations that are appropriate and well-suited for the client processes and culture
• Identifying appropriate standards and applying knowledge relative to data governance and controls in biopharmaceutical GxP related activities
• Solving complex problems in quality, including management of non-conformances, deviations and CAPA
• Leading and negotiating
• Technical writing including SOPs
Preferred Work Experience
• Direct job responsibilities and experience building, configuring, installing and maintaining computerized systems that support manufacturing, engineering, facilities, utilities, maintenance, warehouse, material management and ERP
• Experience with lean and/or six-sigma concepts and projects and use in designing manufacturing and business processes.
• Experience working in manufacturing with responsibilities for overseeing or executing manufacturing operations.
• Experience performing quality system and data audits for manufacturing
• Experience providing regulatory response strategy for citations, e.g. FDA 483s
Educational requirements include:
• B.S. life sciences (chemical, industrial, chemical engineering, or life/pharma sciences)
• 10 years’ minimum experience in or supporting GxP pharmaceutical manufacturing environments
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
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Key areas of expertise:
• All major pharmaceutical manufacturing processes for both simple and complex molecules; biopharmaceuticals a plus.
• Process and/or production engineering
• Deep knowledge of data and processes typically found within the manufacturing, utilities, facilities, maintenance, engineering and warehouse areas
• Computerized systems and IT technologies that support the manufacturing and related environments
• Auditing manufacturing systems and the entire lifecycle of product and related data
• Process mapping and design
• Compliance regulations including 21 CFR part 11 and global guidances for data integrity
• Familiarity with computer validation, equipment qualification, and process validation concepts and approaches
Key Skills:
• Translating detailed data integrity concepts and issues to concise and professional communications for mid- and upper-level management and framing the issues from the right perspective
• Translating regulatory compliance into pragmatic and practical business process and technology solution recommendations
• Analyzing data; Analytical mindset – ability to detect trends and patterns
• Working at all levels from manufacturing technician through upper management
• Conducting GMP audits of facilities and processes for global manufacturing of pharma products
• Making recommendations that are appropriate and well-suited for the client processes and culture
• Identifying appropriate standards and applying knowledge relative to data governance and controls in biopharmaceutical GxP related activities
• Solving complex problems in quality, including management of non-conformances, deviations and CAPA
• Leading and negotiating
• Technical writing including SOPs
Preferred Work Experience
• Direct job responsibilities and experience building, configuring, installing and maintaining computerized systems that support manufacturing, engineering, facilities, utilities, maintenance, warehouse, material management and ERP
• Experience with lean and/or six-sigma concepts and projects and use in designing manufacturing and business processes.
• Experience working in manufacturing with responsibilities for overseeing or executing manufacturing operations.
• Experience performing quality system and data audits for manufacturing
• Experience providing regulatory response strategy for citations, e.g. FDA 483s
Educational requirements include:
• B.S. life sciences (chemical, industrial, chemical engineering, or life/pharma sciences)
• 10 years’ minimum experience in or supporting GxP pharmaceutical manufacturing environments
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
Apply tot his job
Apply To this Job