What are the responsibilities and job description for the Process Engineer position at SCHOTT Pharma?
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 a century. Our company 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.
Key Requirements:
- Bachelor's Degree in Engineering (Mechanical; Industrial; Manufacturing) or related field (required)
- Six Sigma Certifications (preferred)
- 3 years of experience in 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 a fast-paced, matrix-structured organization
Job Summary:
This Process Engineer will propose, plan, implement, and direct major projects involving technical systems. Responsibilities include:
- Leading process mapping and continuous improvement activities of the product line in alignment with set up standards and process flow
- Providing technical support to daily manufacturing, identifying issues, and troubleshooting for effective and efficient resolution
- Performing process monitoring and data analysis, collecting statistical data relating to the manufacturing process, and using SPS techniques to facilitate process improvements
- Owning production processes related to Standard Operating Procedures (SOPs) and Overall Equipment Effectiveness (OEE)
- Using operational and technical expertise to assist in troubleshooting and initiating activities, fostering technology transfer, and participating in Engineering/Production functions to achieve overall plant objectives
- Participating in Engineering activities concerning innovation, design, purchase, fabrication, installation, start-up, and validation of production machinery and processes
- Establishing operating procedures and maintenance requirements for equipment, systems, and processes, and monitoring technical documentation for production and process approvals
- Executing experimental and validation protocols for equipment, processes, and materials
- Supporting product portfolio activities, including technical feasibility, specification changes, and introduction of products
- Instructing and training employees per established guidelines and maintaining good manufacturing practices
- Proposing projects for OEE improvements, cost reductions, feasibility studies, facility layout, and equipment modifications, defining projects to meet cost, quality, and performance requirements
- Assisting in innovation, design, and process developments, serving as a plant key contact and Subject Matter Expert (SME)
- Assisting in defining and developing control strategies and systems for automated manufacturing equipment
- Developing and documenting best practice and lean methods, ensuring standardized procedures
- Helping promote and implement safety/EHS directives and maintaining a clean and safe workspace
- FOLLOWING cGMP AND ADHERING TO ALL ISO AND SAFETY GUIDELINES AND POLICIES
