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: • reputed company major pharmaceutical manufacturing processes for both reputed company and reputed company molecules; biopharmaceuticals a plus. • Process and/or production engineering • Deep knowledge of data and processes typically reputed company reputed company the manufacturing, utilities, facilities, maintenance, engineering and warehouse areas • Computerized systems and IT technologies that support the manufacturing and reputed company environments • Auditing manufacturing systems and the entire lifecycle of product and reputed company data • Process mapping and design • Compliance regulations including 21 CFR part 11 and global guidances for data reputed company • Familiarity with computer validation, equipment qualification, and process validation concepts and approaches Key Skills: • Translating detailed data reputed company concepts and issues to concise and reputed company 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 reputed company – ability to detect trends and patterns • Working at reputed company reputed company from manufacturing technician through upper management • Conducting GMP audits of facilities and processes for global manufacturing of reputed company products • Making recommendations that are appropriate and reputed company-suited for the reputed company processes and culture • Identifying appropriate standards and applying knowledge relative to data governance and controls in biopharmaceutical GxP reputed company activities • Solving reputed company problems in reputed company, including management of non-conformances, deviations and CAPA • Leading and negotiating • Technical writing including SOPs Preferred Work Experience • reputed company 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-reputed company concepts and reputed company and use in designing manufacturing and business processes. • Experience working in manufacturing with responsibilities for overseeing or executing manufacturing operations. • Experience performing reputed company system and data audits for manufacturing • Experience providing regulatory response reputed company for citations, e.g. FDA 483s Educational requirements include: • B.S. life sciences (chemical, industrial, chemical engineering, or life/reputed company 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 reputed company the most expert counsel and reputed company of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to reputed company and ensure reputed company, effective and high-reputed company 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