Specialist Manufacturing
BioPharma Consulting JAD Group
•Onsite
About The Position
With minimal supervision, the Specialist – Manufacturing supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role applies technical, operational, and scientific expertise to support manufacturing operations, troubleshoot issues, and drive continuous improvement. May serve as a process owner for specific systems and support more complex process ownership activities.
Requirements
- Strong understanding of bioprocessing unit operations
- Experience in GMP manufacturing environments
- Knowledge of regulatory requirements and compliance practices
- Ability to troubleshoot manufacturing processes and drive solutions
- Strong technical writing, documentation, and presentation skills
- Effective communication and collaboration across manufacturing, quality, and process development teams
- Basic project management skills
- Knowledge of control charting and process monitoring tools
- Ability to participate in and lead cross-functional teams
- Strong organizational and problem-solving skills
Nice To Haves
- Experience with deviation documentation and investigation processes
- Strong knowledge of Change Control management
- Experience supporting CAPA systems and continuous improvement initiatives
Responsibilities
- Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations
- Serve as document owner for controlled procedures
- Monitor and assess process performance through floor observation and data analysis
- Identify and implement process improvements
- Provide technical troubleshooting support for manufacturing operations
- Assist in developing and delivering technical training materials
- Support establishment of process monitoring parameters and control limits
- Collect and analyze process monitoring data
- Support deviation assessment and quarterly process monitoring reports
- Ensure timely triage of non-conformances
- Author investigation reports and support root cause analysis
- Execute and track corrective and preventive actions (CAPA)
- Manage NC/CAPA closure within established timelines
- Monitor and communicate trend data and recurring issues
- Review equipment/system investigations and support trend evaluations
- Assist in development of process validation protocols and reports
- Support execution of process validation activities
- Collect and analyze validation data
- Support and participate in regulatory inspections
- Ensure adherence to GMP and quality standards
- Participate in NPI activities, assessing requirements for documentation, materials, training, and equipment
- Support process and equipment modifications, including project coordination
- Assist with Change Control (CCCCR) activities impacting manufacturing processes
- Participate in special projects and site initiatives
- Support implementation of process improvements and operational efficiencies
Benefits
- Administrative Shift: Standard business hours
- Overtime: May be required based on business needs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
