Automation Validation Engineer II — Biopharma CSV

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

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.