Senior Process Validation Engineer - Silicone Molding

United Pharma Technologies Inc; Sturtevant (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

A pharmaceutical technology company is seeking Process / Equipment Validation Engineers to support the validation of silicone injection molding machines. This role emphasizes hands-on responsibilities in a fast-paced environment, requiring ownership of validation workstreams and collaborations with various teams to ensure compliance with regulated manufacturing standards. Ideal candidates should have over 5 years of validation experience, particularly within ISO 13485 and GMP frameworks, along with a proven track record of independently managing validation activities.

Qualifications

• 5+ years of experience as a Process or Equipment Validation Engineer.
• Hands-on experience executing IQ/OQ/PQ for manufacturing equipment.
• Strong understanding of equipment qualification and validation lifecycle.

Responsibilities

• Support equipment installation, commissioning, and qualification for silicone injection molding machinery.
• Author, execute, and review validation documentation, including IQ/OQ/PQ protocols and reports.
• Ensure compliance with GMP, ISO 13485, and internal quality system requirements.

Skills

Process Validation

Equipment Validation

GMP

ISO 13485

Risk Assessments

Job description

A pharmaceutical technology company is seeking Process / Equipment Validation Engineers to support the validation of silicone injection molding machines. This role emphasizes hands-on responsibilities in a fast-paced environment, requiring ownership of validation workstreams and collaborations with various teams to ensure compliance with regulated manufacturing standards. Ideal candidates should have over 5 years of validation experience, particularly within ISO 13485 and GMP frameworks, along with a proven track record of independently managing validation activities.