Manager (Automation/Pharma/Medical Device)

NOVEXX PTE. LTD.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A multinational corporation is seeking a skilled Automation Specialist in Singapore to lead the design and implementation of automation solutions within the pharmaceutical sector. The role focuses on ensuring compliance with regulatory standards and cybersecurity while overseeing projects from conception to execution. Ideal candidates will have substantial experience with PLC, SCADA, and MES systems. An attractive salary package is offered.

Benefits

Attractive salary package

Qualifications

• Experience in the Pharmaceutical or medical device industry.
• Knowledge of DI compliance and cybersecurity requirements.
• Ability to manage projects from initial concept through implementation.

Responsibilities

• Act as the primary owner for plant automation systems.
• Lead Industry 4.0 efforts for predictive maintenance and analytics.
• Ensure compliance with 21 CFR Part 11 and support audits.

Skills

Experience in Automation System

Knowledge of compliance and validation standards

Proficiency in SCADA and MES systems

Tools

PLC

SCADA

MES

Job description

Job Scope:

• 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