Alcami Corporation ยท 13 hours ago
Site Engineering, Sr. Process Engineer
US-SC-Charleston
Full-time
Onsite
Senior Level
5+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines. They are seeking a Senior Process Engineer to provide technical support for their manufacturing facility, focusing on process validation, troubleshooting, and efficiency improvements in sterile pharmaceutical manufacturing.
Pharmaceuticals
Responsibilities
Provides technical assistance for process transfer and validation efforts for assigned manufacturing areas
Analyze existing processes, identify areas for improvement, and implement changes to enhance efficiency, reduce costs, and improve product quality
Develop new or modified processes, equipment, and layouts to meet specific production goals
Composes process validation, cleaning validation, or process optimization protocols
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products
Writes validation and technical improvement reports
Monitors manufacturing processes during production runs to assess any technical process issues
Assists technicians in performing physical testing during the aseptic manufacturing operation (e.g. sterilization, depyrogenation, lyophilization, and sanitization)
Participate in investigations and complete CAPA assignments
Utilizes FMEA to trouble shoot processing issues
Participates in Capital Project planning process including identifying requirements, project scope documentation, and review of other engineering design documentation
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Engineering required
Minimum 5+ years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment
Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes
Good verbal and written communication skills
Ability to successfully multitask and prioritize assignments
Good computer skills including Microsoft Office products
Ability to work independently as well as on a team
Preferred
Working knowledge of EU regulations is preferred
Some understanding of pharmaceutical manufacturing and packaging of parenterals principles of technology transfer, process investigations, scale-up, process validation and optimization of liquid fill dosage forms; and lyophilization and sterilization would be helpful
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase