Deviations & CAPA Process Engineer – GMP Manufacturing

United Pharma; Ohio; On-site; USD 85,000 - 110,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Problem solving

Organizational skills

Technical writing

Education

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

Job description

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.