21 CFR Automation Engineering

Experience:

Qualification:

Designation- Senior Executive to Assistant Manager Level

What is 21CFR Automation?

• 21 CFR Part 11

  is an FDA regulation that defines the criteria under which electronic records and signatures are considered reliable and equivalent to paper.
• Roles involving

  21CFR automation engineering

  typically lie at the intersection of automation, computer system validation (CSV), GMP compliance, and process control.

Key Responsibilities:

System Design & Integration

• Design

  ,

  program

  ,

  test

  , and

  implement

  automated systems (PLCs, SCADA) for manufacturing or laboratory use, ensuring they support FDA-regulated processes

Validation & Compliance

• Develop and execute validation documentation

  including URS, FS, DSand protocols such as IQ, OQ, and PQ, all aligned with 21CFR Part 11, cGMP, and GAMP standards
• Ensure compliance with

  data integrity, user security, disaster recovery

  , and system backup provisions per Part 11

Support & Troubleshooting

• Provide

  day-to-day operational support

  , including on-call troubleshooting for upstream/downstream manufacturing systems
• Lead

  rootcause analyses

  for system failures and corrective/preventive action (CAPA) activities

Documentation & Audit Readiness

• Document

  processes, software versions, maintenance logs, and validation reports to maintain audit trails

• Support audits

  ; act as subject-matter expert for internal and regulatory inspections

Cross-Functional Leadership

• Collaborate with

  process engineers, QA, IT, production

  , and external vendors to align automation with operational and compliance requirements .
• Drive

  continuous improvement

  through smart manufacturing

Cybersecurity & Regulatory Controls

• Maintain enterprise-level

  cyber resiliency

  , including OS patching, control system security, and user access compliance

Key Skills and Competencies:

• Hands-on experience with 21 CFR and Automation in Engineering for OSD/Injectable Facility area equipment.
• Good knowledge of cGMP
• Hands on Technical exposure on PLCs,SCADA,HMI
• System specs, trace matrices, IQ/OQ/PQ, CSV per 21CFR Part 11 and cGMP
• Deep knowledge of FDA regulations (Part 11, data integrity, cyber security compliance)
• Troubleshooting, CAPA, on-site support, SOP development

  Role & responsibilities

Preferred candidate profile