Specialist Manufacturing

Summary:
With minimal supervision, the Manufacturing Specialist will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role requires applying process expertise, compliance knowledge, and analytical skills to support manufacturing operations effectively. This position may act as the primary process owner for specific systems and assist with more complex process ownership responsibilities.

Key Responsibilities:

• Initiate, revise, and approve manufacturing procedures to ensure they reflect current operations; act as document owner.
• Assess process performance by observing floor operations and reviewing performance data. Plan and implement solutions for process improvement opportunities.
• Provide troubleshooting support for operational issues.
• Assist in the generation of training materials and provide training on scientific or technical aspects of the process.
• Support the establishment of process monitoring parameters and control limits.
• Collect process monitoring data and assist with assessing deviations.
• Support the timely execution of quarterly process monitoring reports.
• Ensure all non-conformances are triaged within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established timelines and monitor incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist in generating process validation protocols and reports.
• Assist in executing process validations and support the collection and analysis of validation data.
• May participate in regulatory inspections as required.
• Participate in the New Product Introduction (NPI) process, assessing requirements for documentation, materials, training, and equipment modifications.
• Assist in assessing, prioritizing, and providing project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate in the assessment or implementation of special projects or initiatives.

Competencies/Skills:

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge and experience with regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Strong communication and collaboration skills with technical and management staff.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Education & Experience:

• Doctorate degree, OR
• Master’s degree and 3 years of Manufacturing Operations experience, OR
• Bachelor’s degree and 5 years of Manufacturing Operations experience, OR
• Associate’s degree and 10 years of Manufacturing Operations experience, OR
• High school diploma/GED and 12 years of Manufacturing Operations experience.

Preferred Qualifications:

• A background in Sciences or Engineering.
• Experience in Manufacturing Operations.

Shift: 8:00 AM – 5:00 PM