Manager (Automation/Pharma/Medical Device)

Novexx Pte Ltd; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A multinational corporation is seeking an automation expert in Singapore to oversee plant automation systems. The role involves defining compliance measures, leading automation projects, and providing technical mentorship. Ideal candidates will have extensive experience in the pharmaceutical or medical device sector along with a strong grasp of advanced automation technologies. An attractive salary package is offered for the right candidate who can drive continuous improvement and digitalization efforts.

Benefits

Attractive salary package

Qualifications

• Experience in Pharmaceutical or medical device industry.
• Strong knowledge in DI compliance and advanced automation systems.

Responsibilities

• Act as the primary owner for plant automation systems.
• Create and deploy automation solutions for processes.
• Lead Industry 4.0 efforts and continuous improvement initiatives.

Skills

Experience in Automation System

GAMP 5 validation

Cybersecurity

SCADA

MES

PLC

Job description

Job Scope:

Automation System Ownership

• Act as the primary owner for plant automation systems (PLC, SCADA, MES, historians).
• Ensure systems meet data integrity, cybersecurity, and regulatory standards.
• Keep all automation platforms in a validated, compliant state in line with GAMP 5 and cGMP requirements.

Design & Implementation

• Create and deploy automation solutions for both new and existing processes, including integration with digital manufacturing platforms.
• Serve as SME and reviewer for URS, FS, SDS, HDS, and validation deliverables.
• Participate in or lead FAT, SAT, and IQ/OQ/PQ qualification activities for automation projects.

Continuous Improvement & Digitalization

• Lead Industry 4.0 efforts such as predictive maintenance, real-time analytics, and smart sensor technologies.
• Use Lean and Six Sigma tools to streamline automated processes and minimize downtime.
• Apply advanced process control methods and best practices in alarm management.

Project Management

• Oversee automation projects from initial concept through implementation, managing budgets, timelines, and suppliers.
• Deliver automation upgrades and expansions on schedule and aligned with operational priorities.

Technical Leadership & Training

• Provide expert support and mentorship to operations and maintenance personnel.
• Develop and deliver training programs focused on automation troubleshooting and system performance improvement.

Compliance & Governance

• Ensure compliance with 21 CFR Part 11, GAMP 5, and cybersecurity requirements.
• Support internal and external audits and regulatory inspections related to automation and metrology systems.

Requirements:

• Experience in Automation System in Pharmaceutical or medical device industry
• Experience in DI compliance, GAMP 5 validation, cybersecurity, SCADA, MES, historian systems, PLC

Multinational corporation

Attractive salary package