Chemical Manufacturing Engineer

SUMMARY:

We are looking for a skilled Manufacturing Engineer to design, develop,

and implement manufacturing processes and equipment for our pharmaceutical

products. The successful candidate will work closely with cross-functional

teams to ensure compliance with regulatory requirements, improve product

quality, and optimize manufacturing efficiency.

RESPONSIBILITES:

• Design and develop manufacturing processes, equipment, and facilities to meet production requirements
• Collaborate with process development scientists to develop and validate manufacturing processes for new products
• Conduct root cause analysis and implement corrective actions for manufacturing defects or issues
• Develop and maintain process documentation, including standard operating procedures (SOPs), batch records, and technical specifications
• Conduct audits and inspections of manufacturing facilities to ensure compliance with regulatory requirements
• Work closely with quality assurance team to resolve quality issues and implement corrective actions
• Identify opportunities for process improvements and implement changes to reduce costs, improve efficiency, and increase productivity
• Collaborate with procurement team to source equipment and materials
• Participate in continuous improvement initiatives to drive manufacturing excellence
• Develop and maintain relationships with suppliers and contract manufacturers
• Stay up-to-date with industry trends, regulatory requirements, and technological advancements

QUALIFICATIONS:

• Bachelor's degree in Chemical Engineering, Sciences, or related field
• 5+ years hands-on experience as a Service Engineer is preferred, particularly working with analytical instrumentation in particular Chromatography.
• Hands-on experience with benchtop laboratory instrumentation systems
• Strong knowledge of Good Manufacturing Practices (GMPs) and regulatory requirements (e.g., FDA, EMA)
• Experience with manufacturing processes such as lyophilization, crystallization, filtration, and sterilization
• Experience with Chromatography (Cytiva AKTA FPLC, Agilent & Waters HPLC, Waters UPLC)
• Liquid Handler Experience (Agilent BRAVO)
• Strong analytical and problem-solving skills
• Excellent communication and collaboration skills
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and experience with process control systems (e.g., MES, ERP)
• Familiarity with lean manufacturing principles and continuous improvement methodologies (e.g., Six Sigma)