Specialist Manufacturing

The Specialist Manufacturing supports the execution and continuous improvement of manufacturing and quality systems, including non-conformances, CAPA, change control, process validation, procedures, training, and new product introductions (NPI). Working with minimal supervision, this role applies operational, scientific, and technical expertise to support GMP manufacturing operations, improve process performance, and ensure compliance with quality and regulatory requirements. The Specialist may serve as a process owner for assigned manufacturing systems and collaborate with cross-functional teams to support operational excellence initiatives.

Key Responsibilities

• Initiate, revise, review, and approve manufacturing procedures and SOPs while ensuring documentation reflects current operations.
• Serve as a document owner for manufacturing procedures and controlled documentation.
• Evaluate manufacturing processes through floor observations, process data, and performance metrics.
• Identify and implement process improvements to enhance efficiency, quality, and compliance.
• Provide technical troubleshooting support for manufacturing operations.
• Support the implementation of new manufacturing processes and equipment modifications.
• Establish and monitor process parameters and control limits.
• Collect, analyze, and interpret process monitoring data.
• Support the preparation, execution, and documentation of process validation activities.
• Assist in the completion of routine process monitoring reports and trend analyses.
• Ensure deviations and non-conformances are assessed and processed within established timelines.
• Conduct deviation assessments and author investigation reports.
• Execute and monitor Corrective and Preventive Actions (CAPA) through completion.
• Support root cause investigations and evaluate effectiveness of corrective actions.
• Monitor, analyze, and communicate quality and manufacturing trends.
• Support Change Control activities and documentation updates.
• Develop new procedures and revise existing SOPs as needed.
• Create training materials and provide training to manufacturing personnel on procedures and process changes.
• Participate in internal and external audits and regulatory inspections.
• Support New Product Introductions (NPI) by coordinating documentation, training, materials, and equipment readiness.

Skills

• Strong knowledge of GMP manufacturing operations and quality systems.
• Understanding of bioprocessing or manufacturing unit operations.
• Experience with process monitoring, data analysis, and trend evaluation.
• Excellent analytical and problem-solving skills.
• Strong technical writing and documentation abilities.
• Effective communication and collaboration skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Basic project management skills.
• Knowledge of control charting and continuous improvement methodologies.

Qualifications

• Doctorate, OR
• Master's degree with 2+ years of Manufacturing Operations experience, OR
• Bachelor's degree with 4+ years of Manufacturing Operations experience, OR
• Associate degree with 8+ years of Manufacturing Operations experience, OR
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Preferred Qualifications

• Experience in biotechnology, pharmaceutical, or other regulated manufacturing environments.
• Experience supporting GMP manufacturing operations and quality systems.
• Hands-on experience with:
• Deviations and investigations
• CAPA management
• Change Control
• SOP development and document management
• Process improvements and implementation
• Operator training
• Experience using quality and manufacturing systems such as SAP, TrackWise, electronic batch records (PAS/X), Veeva, or similar document management systems.

• Administrative Shift
• Contract position