• Coordinates all work related to Process Engineering deliverables on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments.
• Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers.
• Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers and works closely with the overall Tech Transfer team.
• Works closely with technical services to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation. Develops and delivers presentations to communicate project timelines and milestone completions.
• Serve as the Subject Matter Expert for equipment and processes within area of responsibility and thereby serving as the SME for investigations, design reviews, equipment/process troubleshooting, Capital Project planning, change control and other related activities for the site.
• Able to work well in cross-functional TEAMS, good communication and presentation skills, strong technical understanding, general automation knowledge, multi-tasking and time management.
• Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors.
• Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work.
• Identify and execute projects to increase safety, reduce product cost, improve product quality, improve yield, and reduce material usage.
• Work on several different projects and be able to prioritize these projects.
• Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, alarm points, and automation strategy.
• Authors, updates, reviews, and approves area procedures and master batch records to ensure correct content and compliance with Good Manufacturing Practices.
• Designs studies, executes experiments and performs data analysis.
• Writes study proposals, progress reports, development reports, and various technical memos.
• Evaluates new technologies to improve the commercial production process.
• Supports scale-up activities from R&D to production.
• Provides miscellaneous overhead support of facility.
• Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch.
• Sets up robust process for troubleshooting.
• Acts as an effective change agent.
• Acts as a key player for the expansion of projects as needed to increase scale of manufacture.
• Investigate deviations from standards of manufacturing process using effective root cause analysis tools, recommending and implementing effective corrective and preventative actions.
• Generating, evaluating, and implementing innovative and creative solutions.
• Assist as subject matter expert for technical projects.
• Capable of generating a project scope and cost plan to effectively draft a capital request.
• Develops product and process knowledge in multiple process train areas.
• Contributes to equipment URS development and retrofit. Participates in equipment FAT’s, SAT’s, etc.
• Participate in Quality Risk Assessments and process hazards analysis activities.
Our requirements:
- Min Degree in Biomedical Engineering/Biomedical Sciences
- Min of 2-5 years experience in Process Engineering
- Must possess excellent teamwork and interpersonal skills with a strong emphasis on good analytical skills
- Possess good customer interactions skills
- Sound ability to troubleshoot and repair
- Good communication skills
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