Senior Bioprocess Automation Engineer - SCADA & Validation

ProBio; Pennington (NJ); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision Insurance

401(k) with company match

Parental leave

Paid time off + holidays

Job summary

ProBio Inc. in Pennington, NJ, is seeking a Sr. Automation Engineer to lead administration and validation of the site’s automation systems, including SCADA and PLCs.

You will coordinate changes, validation protocols, and lifecycle documents across IT, Manufacturing, Facilities & Engineering, QC, and QA, ensuring compliance with cGxP and regulatory standards. The role requires a BS in engineering with 8–10 years of automation experience in biologics production, familiarity with Rockwell/DeltaV,

Qualifications

• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field with 8–10 years of experience.
• Expertise in IT Networking and industrial automation systems (Rockwell, Wonderware, DeltaV, etc.).
• Experience as IT Automation Engineer or similar role.
• Knowledge of regulatory guidelines for validation of computerized equipment and automation systems (FDA, ICH, USP, EMEA).
• Proficiency with office software and specialized QA/ manufacturing tools (Veeva Vault, SAP, Maximo).
• Strong problem-solving, prioritization, and cross-functional collaboration skills.

Responsibilities

• Define and manage automation system requirements and validation plans.
• Collaborate with Area Managers, System Owners, and Users for onboarding, operation, and retirement of systems.
• Develop validation protocols, reports, and lifecycle documents.
• Execute validation protocols and collect evidence.
• Create and improve administration SOPs for automation systems.
• Monitor system integrity, availability, performance, and operability.
• Investigate and resolve technical issues including root-cause analysis.
• Apply patches/upgrades following Change Control processes.
• Understand network, system, and cloud-based operations.
• Manage user access and regulatory compliance.
• Maintain knowledge of current tech trends in bioprocess equipment.
• Author change controls and test scripts as SME for automation changes.
• Recommend new equipment and Process Analytical Technologies (PAT).
• Coordinate Change Request processes with QA, IT, and Managed Services.
• Provide training on cGxP, GMP, GxP, and related directives and safety measures.

Skills

Problem-solving

Collaboration

Communication

Prioritization

Onsite work

Education

Bachelor of Science in Electrical Engineering

Tools

Rockwell Automation

Wonderware ArchestrA

FactoryTalk View SE

TopView

Vaisala ViewLinc

Unicorn

DeltaV

Repligen instruments

Thermo Scientific instruments

SAP

Maximo

Veeva Vault

Job description

ProBio Inc. in Pennington, NJ, is seeking a Sr. Automation Engineer to lead administration and validation of the site’s automation systems, including SCADA and PLCs.

You will coordinate changes, validation protocols, and lifecycle documents across IT, Manufacturing, Facilities & Engineering, QC, and QA, ensuring compliance with cGxP and regulatory standards. The role requires a BS in engineering with 8–10 years of automation experience in biologics production, familiarity with Rockwell/DeltaV,