Job Description

Process Engineer (Sterile Vials)

Company Overview:

SCHOTT Pharma USA has been providing advanced solutions and services to the global pharmaceutical and biotechnology industries for over 100 years. SCHOTT Pharma USA offers an extensive and scientifically proven product portfolio including vials, syringes, cartridges and Fast Track Kits, for the safe storage and administration of injectable drugs worldwide.

Skills/Experiences:

• Bachelor’s Degree in Engineering (Mechanical; Industrial; Manufacturing) or related field (required)
• Six Sigma Certifications (preferred)
• Experience (3+ years) of relevant Process/Mechanical engineering in a regulated setting
• Demonstrated proficiency with SolidWorks and CAD
• Proven knowledge of cGMP and ISO Standards (9001; 13485; 15378)
• Proven knowledge related to cGMP and validation processes (preferred)
• Demonstrated communication skills (written / oral) including the ability to read/speak English
• Ability and willingness to work in fast-paced, matrix structured organization

Summary/Responsibilities:

This Process Engineer will propose, plan, implement and direct major projects involving technical systems. Projects include: continuous improvement measures, risk management, and process development. Other potential duties/expectations:

• Lead process mapping and continuous improvement activities of the product line in alignment with set up standards and process flow.
• Provide technical support to daily manufacturing; identify issues and/or problems and troubleshoot for effective and efficient resolution.
• Perform process monitoring and data analysis, in addition to, collecting statistical data relating to the manufacturing process SPS techniques to facilitate process improvements.
• Provide ownership over production processes related to Standard Operating Procedures (SOPs) and the Overall Equipment Effectiveness (OEE).
• Use operational and technical expertise to assist in troubleshooting and initiating activities and fostering technology transfer; participate in Engineering/Production functions to achieve overall plant objectives.
• Participate in Engineering activities concerning the innovation, design, purchase, fabrication, installation, start-up and validation of production machinery and processes.
• Establish operating procedures and maintenance requirements for equipment, systems and processes and monitor the technical documentation for the production and process approvals; in addition to; managing the execution of relevant process activities by following established SOPs
• Execute experimental and validation protocols for equipment, processes, and materials
• Support product portfolio activities including technical feasibility, specification changes and introduction of products.
• Instruct and train employees per established guidelines and maintain good manufacturing practices.
• Propose projects for OEE improvements, cost reductions, feasibility studies, facility layout and equipment modifications; scope and define projects to meet cost, quality and performance requirements.
• Assist in innovation, design and process developments, while serving as plant key contact and Subject Matter Expert (SME).
• Assist in defining and developing control strategies and systems for automated manufacturing equipment.
• Develop and document best practice and lean methods; ensure standardized procedures
• Help promote and implement safety/EHS directives and maintain a clean and safe workspace.
• Follow cGMP and adhere to all ISO and safety guidelines and policies.

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