Validation Engineer

United Pharma Technologies Inc; Wisconsin; On-site; USD 62,000 - 76,000; Full time

Job summary

United Pharma Technologies Inc is seeking an experienced Validation / Quality Engineer to support manufacturing validation, equipment qualification, process improvement, and compliance activities for a regulated medical device manufacturing facility.

The ideal candidate will have hands-on experience executing validation protocols and supporting Quality System activities in accordance with ISO 13485 and FDA medical device requirements, including IQ/OQ/PQ, CAPA, NCR, deviations, and process-risk

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Experience in medical device manufacturing.
• Hands-on experience with Process Validation, IQ/OQ/PQ, and Equipment Qualification.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 / QMSR.
• Strong technical writing and cross-functional communication.

Responsibilities

• Execute IQ, OQ, PQ and Process Validation activities for manufacturing equipment and processes.
• Develop validation plans, protocols, test scripts, reports, and supporting documentation.
• Support equipment installation, commissioning, qualification, and requalification.
• Identify validation and compliance gaps and drive corrective actions.
• Support validation-related: CAPAs, Deviations, Nonconformances, Investigations, Change Controls.
• Conduct risk assessments including PFMEA and process-risk analysis.
• Participate in manufacturing process development and process optimization.
• Support manufacturing transfers, equipment changes, and process changes.
• Perform statistical analysis to establish process capability and acceptance criteria.
• Support FDA, ISO, internal, and customer audit readiness activities.
• Review existing validation documentation and support remediation activities.
• Ensure appropriate documentation and traceability throughout the validation lifecycle.

Skills

Process Validation

IQ/OQ/PQ

Equipment Qualification

CAPA / NCR / Deviations

Statistical Analysis

Documentation

Cross-functional Communication

Quality System Knowledge

Education

Bachelor’s degree in Engineering

Job description

Industry: Medical Device / FDA-Regulated Manufacturing

Experience: 5+ Years

Pay: $45-55/hr on W2

Industry: Medical Device Manufacturing

Position Overview:

We are seeking an experienced Validation / Quality Engineer to support manufacturing validation, equipment qualification, process improvement, and compliance activities for a regulated medical device manufacturing facility.

The ideal candidate will have strong hands-on experience executing validation protocols and supporting Quality System activities in accordance with ISO 13485 and FDA medical device requirements.

Key Responsibilities

• Execute IQ, OQ, PQ and Process Validation activities for manufacturing equipment and processes.
• Develop validation plans, protocols, test scripts, reports, and supporting documentation.
• Support equipment installation, commissioning, qualification, and requalification.
• Identify validation and compliance gaps and drive corrective actions.
• Support validation-related:
• CAPAs
• Deviations
• Nonconformances
• Investigations
• Change Controls
• Conduct risk assessments including PFMEA and process-risk analysis.
• Participate in manufacturing process development and process optimization.
• Support manufacturing transfers, equipment changes, and process changes.
• Perform statistical analysis to establish process capability and acceptance criteria.
• Support FDA, ISO, internal, and customer audit readiness activities.
• Review existing validation documentation and support remediation activities.
• Ensure appropriate documentation and traceability throughout the validation lifecycle.

Required Qualifications

• Bachelor’s degree in Engineering or another related technical discipline.
• Previous experience in medical device manufacturing.
• Strong hands-on experience with:
• Process Validation
• IQ/OQ/PQ
• Equipment Qualification
• Validation Protocol Execution
• CAPA / NCR / Deviations
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 / QMSR.
• Strong technical writing, documentation, and cross-functional communication skills.