Manufacturing Scientist
About The Position
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands. The Manufacturing Scientist I will provide temporary Manufacturing Sciences support for manufacturing process improvement and validation activities at the Rockford, IL site. The role focuses on bead and resin manufacturing process and capacity improvements, as well as qualification and validation of processing equipment. The scientist will collaborate with Manufacturing Sciences, Operations, Engineering, Quality, and other cross-functional teams to plan and execute equipment and process validation activities, analyze experimental and manufacturing data, prepare validation documentation, troubleshoot manufacturing processes and equipment, and support the implementation of process improvements and validated processes into routine manufacturing.
Requirements
- Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific or engineering discipline.
- 2+ years of relevant laboratory, manufacturing, process development, or validation experience.
- Experience planning and executing laboratory or manufacturing experiments with limited guidance.
- Experience with equipment qualification, process validation, or manufacturing process improvement.
- Experience working with manufacturing equipment and supporting equipment or process implementation.
- Experience in a regulated manufacturing environment with familiarity with ISO/GMP quality systems.
- Strong technical documentation and data analysis skills.
- Proficiency with Microsoft Excel, Word, and PowerPoint.
- Experience with statistical analysis software such as Minitab, JMP, or Design Expert.
- Familiarity with validation lifecycle documentation, including protocols, data analysis, and final reports.
- Strong analytical, troubleshooting, organizational, and communication skills.
- Ability to work effectively in a hands-on manufacturing environment and collaborate with cross-functional teams.
Nice To Haves
- Experience with chromatography, bead and resin manufacturing, bioprocessing, or related manufacturing processes is preferred.
- Experience with root cause analysis, process troubleshooting, and continuous improvement methodologies.
Responsibilities
- Support the planning and execution of equipment qualification and process validation activities.
- Execute validation studies supporting bead and resin manufacturing process improvements and capacity expansion.
- Develop and execute validation protocols and experimental plans with guidance from project leads.
- Perform hands-on laboratory and manufacturing-floor activities related to equipment and process validation.
- Collect, organize, and analyze experimental and manufacturing data using appropriate statistical methods.
- Prepare validation protocols, reports, technical summaries, and supporting documentation.
- Partner with Operations and Engineering to troubleshoot equipment and manufacturing process issues.
- Support process characterization, optimization, and continuous improvement activities for desalting resin manufacturing.
- Assist with implementation of validated processes and equipment into routine manufacturing.
- Ensure documentation complies with applicable SOPs, quality systems, and internal requirements.
- Communicate project status, experimental results, risks, and recommendations to cross-functional stakeholders.
- Support additional Manufacturing Sciences validation and manufacturing troubleshooting activities based on project priorities.
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What This Job Offers
Career Level
Entry Level
