Engineer II, Automation Validation

Scorpion Therapeutics; Hopewell (NJ); On-site; USD 95,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking a Support Automation Validation specialist to ensure CSV compliance and robust project delivery at a biopharma manufacturing site.

You will develop and lead validation activities for automation systems (PLC, HMI, SCADA, DCS, vision, data acquisition), perform risk assessments, review equipment specifications, and manage validation projects with up to 5% travel; site-based with gowning in manufacturing suites.

Qualifications

• BS in engineering or scientific discipline required.
• Minimum 3–4 years validation experience in FDA-regulated biotech/pharma manufacturing.
• Knowledge of cGMP, data integrity, risk-based approaches, and sterile/aseptic processing.

Responsibilities

• Develop and approve cGMP validation documents.
• Lead validation activities for automation systems (PLC, HMI, SCADA, DCS, vision, data acquisition).
• Participate in system design reviews and perform risk assessments.
• Manage validation projects and resources; review equipment specifications.
• Investigate validation discrepancies.

Skills

Validation

Data integrity

cGMP

Risk-based approaches

Sterile processing

Education

BS in engineering or scientific discipline

Tools

Microsoft Office

SAP

Job description

Role:

Support Automation Validation and Computerized Systems Validation (CSV) functions within a biopharma manufacturing site, ensuring regulatory compliance, operational efficiency, and successful project delivery.

Responsibilities:

develop and approve cGMP validation documents, lead validation activities for automation systems (PLC, HMI, SCADA, DCS, vision, data acquisition), participate in system design reviews, perform risk assessments, manage validation projects and resources, review equipment specifications, and investigate validation discrepancies.

Requirements:

BS in engineering or scientific discipline (pharmaceutical sciences, chemistry, engineering), minimum 3-4 years validation experience in FDA-regulated biotech/pharma manufacturing, knowledge of cGMP, data integrity, risk-based approaches, and sterile/aseptic processing.

Preferred:

experience with CSV, automation validation, and IT tools like Microsoft Office and SAP.

HighValue:

validation of automated manufacturing systems supporting sterile biotech processes, compliance with GxP, and involvement in audits.

Work setup:

site-based with gowning in manufacturing suites, with up to 5% travel.