Specialist Manufacturing

BioPharma Consulting JAD Group

3d

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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

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

Benefits

• Administrative shift
• 6-month contract

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 1-10 employees