Process Engineer - Manufacturing Deviations & CAPA

United Pharma; Ohio; Presencial; USD 85 000 - 110 000; Tempo integral

Resumo da oferta

United Pharma is seeking a Process Engineer to provide technical support to manufacturing process owners in a regulated pharmaceutical environment. You will review process data, batch records, and manufacturing flows to assist deviation investigations and CAPA formation.

The role requires collaborating with QA, manufacturing, and other functions to implement corrective actions and ensure documentation meets GMP site procedures. Strong analytical and writing skills are essential.

Qualificações

• Bachelor's degree in chemical/biochemical/pharmaceutical engineering or a related field.
• Experience in regulated GMP pharmaceutical manufacturing.
• Experience supporting deviation investigations, root cause analysis, and CAPA development.
• Working knowledge of GMP requirements and pharmaceutical documentation.
• Experience reviewing batch records, process data, SOPs, and controlled documentation.
• Strong analytical, problem-solving, organizational, and technical writing skills.

Responsabilidades

• Provide technical engineering support to manufacturing process owners during deviation investigations, including reviewing process data, batch records, and process flows.
• Support root cause analysis and evaluate potential process impacts of deviations and nonconformances.
• Collaborate with process owners and stakeholders to define CAPAs based on investigation findings.
• Plan, execute, document, and track CAPA actions through completion and closure.
• Identify and communicate updates to SOPs, batch records, and manufacturing instructions due to deviations and CAPAs.
• Provide input to ensure corrective actions address identified process issues and drive improvements.
• Collaborate with Manufacturing, QA, and other functions to resolve process-related issues.
• Maintain accurate, complete, and timely documentation per GMP requirements.

Conhecimentos

Analytical skills

Problem solving

Organizational skills

Technical writing

Formação académica

Bachelor's degree in Chemical/ Biochemical/ Pharmaceutical Engineering or related field

Descrição da oferta de emprego

Our client seeks a Process Engineer to provide technical support to manufacturing process owners in a regulated pharmaceutical manufacturing environment. The successful candidate will provide technical input to deviation investigations and CAPA definition, including reviewing process data, batch records, and manufacturing process flows.

Key Responsibilities

• Provide technical engineering support to manufacturing process owners during deviation investigations, including the review and interpretation of process data, batch records, and manufacturing process flows.
• Support root cause analysis and evaluate potential process impacts associated with manufacturing deviations and nonconformances.
• Collaborate with process owners and relevant stakeholders to define appropriate corrective and preventive actions (CAPAs) based on investigation findings.
• Support the planning, execution, documentation, and tracking of process-related CAPA actions through completion and closure.
• Identify and communicate required updates to standard operating procedures (SOPs), batch records, manufacturing instructions, and other controlled documents resulting from deviations and CAPAs.
• Provide technical input to ensure proposed corrective actions address identified process issues and support sustainable improvements.
• Collaborate with Manufacturing, Quality Assurance, and other relevant functions to facilitate effective resolution of process-related issues.
• Maintain accurate, complete, and timely documentation in accordance with applicable GMP requirements and site procedures.

Qualifications and Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related engineering or scientific discipline.
• Experience in pharmaceutical, biopharmaceutical, or another regulated GMP manufacturing environment.
• Experience supporting manufacturing deviation investigations, root cause analysis, and CAPA development or implementation.
• Working knowledge of GMP requirements and pharmaceutical manufacturing documentation.
• Experience reviewing batch records, manufacturing process data, SOPs, and other controlled documentation.
• Strong analytical, problem-solving, organizational, and technical writing skills.
• Ability to collaborate effectively with process owners and cross-functional teams and manage assigned actions through completion.

Preferred Qualifications

• Experience supporting process troubleshooting and manufacturing investigations in a pharmaceutical production environment.
• Familiarity with electronic quality management systems (eQMS) and deviation/CAPA tracking processes.
• Experience supporting continuous improvement initiatives and manufacturing process improvements.
• Experience in biologics, sterile manufacturing, or other specialized pharmaceutical manufacturing operations.