Process Validation Engineer

United Pharma; North Carolina; On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma is seeking an experienced Process Validation Engineer to support validation and PPQ activities within a GMP manufacturing environment. You will develop and execute validation protocols, review data, and work cross-functionally with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.

Responsibilities include reviewing plans, coordinating readiness, collecting and analyzing process data, investigating deviations, and preparing comprehensive validation reports to

Qualifications

• Hands-on experience with Process Validation and PPQ in a GMP manufacturing environment.
• Experience implementing deviations, CAPA, change control, and data integrity.
• Ability to coordinate with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
• Solid understanding of CPPs, CQAs, CPV, GDP, and GMP requirements.
• Experience with sterile/aseptic manufacturing, cleaning validation, sterilization, and process simulation is preferred.

Responsibilities

• Review existing validation plans, process documentation, risk assessments, batch records, SOPs, and qualification packages to identify gaps and required updates.
• Develop, revise, and execute Process Validation and PPQ protocols, sampling plans, acceptance criteria, and traceability documentation.
• Coordinate validation readiness and execution activities with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
• Execute process validation and PPQ activities on the manufacturing floor in accordance with approved protocols and GMP requirements.
• Collect, analyze, and review process data, test results, equipment parameters, and supporting documentation to confirm that acceptance criteria are met.
• Review completed validation protocols for accuracy, data integrity, and GDP compliance.
• Investigate protocol discrepancies, execution issues, and unexpected results; document deviations and support root-cause investigations and CAPA.
• Prepare comprehensive validation reports summarizing execution results, deviations, conclusions, and recommendations.
• Monitor validation protocol status, open actions, risks, dependencies, manufacturing activities, and sampling schedules to ensure timely completion.

Skills

Process Validation

PPQ

GMP

Data Analysis

CAPA

Change Control

Root-Cause Investigation

Cross-functional Collaboration

Documentation

Job description

We are seeking an experienced Process Validation Engineer to support process validation and PPQ activities within a GMP-regulated manufacturing environment. The ideal candidate will have hands‑on experience with validation protocols, manufacturing documentation, data analysis, deviations, and cross‑functional coordination.

Key Responsibilities:

• Review existing validation plans, process documentation, risk assessments, batch records, SOPs, and previous qualification packages to identify gaps and required updates.
• Develop, revise, and execute Process Validation and PPQ protocols, sampling plans, acceptance criteria, and traceability documentation.
• Coordinate validation readiness and execution activities with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
• Execute process validation and PPQ activities directly on the manufacturing floor in accordance with approved protocols and GMP requirements.
• Collect, analyze, and review process data, test results, equipment parameters, and supporting documentation to confirm that established acceptance criteria are met.
• Review completed validation protocols for accuracy, completeness, data integrity, and compliance with Good Documentation Practices (GDP).
• Investigate protocol discrepancies, execution issues, and unexpected results; document deviations, support root‑cause investigations, and track corrective actions through closure.
• Prepare comprehensive validation reports summarizing execution results, deviations, conclusions, and recommendations.
• Monitor validation protocol status, open actions, risks, dependencies, manufacturing activities, and sampling schedules to ensure timely completion.

Required Experience:

• Hands‑on experience in Process Validation and PPQ within a GMP manufacturing environment.
• Strong experience developing and executing validation protocols and reports.
• Experience with deviations, CAPA, Change Control, risk assessments, and data integrity.
• Experience working directly with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
• Understanding of CPPs, CQAs, CPV, GDP, and GMP requirements.
• Experience with sterile/aseptic manufacturing, cleaning validation, sterilization, process simulation, and environmental monitoring is highly preferred.