The Specialist Manufacturing will support the execution of various manufacturing and quality systems with minimal supervision.
This role includes managing non-conformances, process validation, procedural updates, training, and new product introductions.
The specialist will apply operational, scientific expertise and basic compliance knowledge to assist in troubleshooting and continuous process improvement efforts.
This individual may also act as the primary production process owner for support systems and assist with more complex process ownership responsibilities.
Responsibilities: Initiate, revise, and approve manufacturing procedures, ensuring all documentation reflects current operational practices.
Assess process performance through floor observation and data review to identify and implement process improvements.
Provide technical troubleshooting support for manufacturing operations.
Assist in the development of training materials and provide technical training on manufacturing processes as needed.
Collect and assess process-monitoring data and support the establishment of control limits and parameters.
Assist in the timely execution of quarterly process monitoring reports.
Manage and triage non-conformances to meet established goals.
Author investigation reports and manage corrective actions (CAPA).
Monitor incident trends and assist in root cause analysis for equipment and system investigations.
Assist in generating and executing process validation protocols and reports.
Support data collection and analysis for validation processes.
Participate in regulatory inspections as needed, ensuring compliance with relevant standards and practices.
Support new product introduction processes, assessing documentation, materials, training, and equipment modification requirements.
Provide project management support for process or equipment modifications.
Assist in managing manufacturing change requests affecting processes.
Participate in the assessment and implementation of special projects or initiatives within the organization.
Skills & Competencies: Strong understanding of bioprocessing unit operations and GMP production.
Skilled in handling deviations and non-conformance investigations.
Expertise in technical writing, report development, and project management.
Experience with root cause analysis tools (e.g., causal factors analysis, 5 Why's).
Basic project management skills, with a focus on identifying and tracking actions to meet deadlines.
Ability to collaborate effectively across teams, including manufacturing, process development, and quality departments.
Strong organizational, communication, and technical writing skills.
Requirements Qualifications: 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: Experience managing deviations and non-conformance investigations.
Strong technical writing and report development skills.
Knowledge of root cause analysis methodologies.
Proficient in project management and driving results within timelines.