With minimal supervision, the Manufacturing Specialist supports the execution and continuous improvement of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions (NPI). This role applies process, operational, and scientific expertise along with compliance knowledge to support manufacturing operations, troubleshoot issues, and enhance process performance. The specialist may serve as a process owner for defined systems and support more complex operations.
Key Responsibilities
- Author, revise, and approve manufacturing procedures; serve as document owner
- Ensure procedures accurately reflect current operations and compliance requirements
- Monitor and assess process performance through floor observation and data analysis
- Identify, plan, and implement process improvements
- Provide technical troubleshooting support to manufacturing operations
- Develop and support training materials; assist in technical training delivery
- Support establishment of process monitoring parameters and control limits
- Collect and analyze process monitoring data
- Assist in deviation assessment and resolution
- Support the preparation and timely execution of quarterly process monitoring reports
- Ensure timely triage of non-conformances (NCs)
- Author investigation reports and support root cause analysis
- Execute and track corrective and preventive actions (CAPAs)
- Drive closure of NC/CAPA within established timelines
- Monitor and communicate trends in deviations and incidents
- Review and support equipment/system root cause investigations
- Support development of validation protocols and reports (IQ/OQ/PQ)
- Assist in execution of validation activities
- Collect, analyze, and summarize validation data
- Support regulatory inspections and audit readiness activities
- Ensure compliance with cGMP and internal quality standards
- Participate in NPI activities, including assessment of documentation, materials, training, and equipment needs
- Support implementation of process and equipment modifications
- Assist in change control processes (CCRB), including documentation and impact assessment
- Participate in cross-functional projects and initiatives
- Support implementation of process improvements and operational excellence efforts
- Provide basic project management support for manufacturing-related projects
Core Competencies
- Technical expertise in manufacturing processes and equipment
- Strong troubleshooting and analytical problem-solving skills
- Knowledge of regulatory requirements and compliance (cGMP)
- Ability to work and collaborate across cross-functional teams
- Effective communication with technical and management personnel
- Organizational skills and attention to detail
- Technical writing and documentation skills
- Basic project management capabilities
- Knowledge of statistical tools such as control charting
Requirements
Education & Experience
- Doctorate, OR
- Master’s degree + 2 years of Manufacturing Operations experience, OR
- Bachelor’s degree + 4 years of Manufacturing Operations experience, OR
- Associate’s degree + 8 years of Manufacturing Operations experience, OR
- High School Diploma/GED + 10 years of Manufacturing Operations experience
Preferred Qualifications
- Experience with deviation documentation and Change Control Management
- Strong knowledge of bioprocessing unit operations
- Experience in GMP-regulated manufacturing environments
- Familiarity with process validation and quality systems
Benefits
- Administrative shift
- 6-month contract
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
