Senior Operations Engineer 1

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading biopharma company is seeking a Senior Operations Engineer to enhance manufacturing processes and support operational objectives. This role involves process optimization, training, and project management while ensuring compliance with cGMP. The ideal candidate will possess a relevant degree and significant experience in pharmaceutical manufacturing, and demonstrate strong leadership skills to coach junior engineers.

Qualifications

• Minimum 4 years experience in biologics or pharmaceutical manufacturing.
• Knowledge of cGMP and biosafety.
• Experience with biotechnology equipment and downstream processes.

Responsibilities

• Manage deviation investigations and CAPAs related to complex process events.
• Conduct gap analysis against QMS and prepare supporting documents.
• Coach and guide Operations Engineers in daily tasks.

Skills

Communication

Problem-solving

Team-building

Analytical skills

Education

Degree in Chemical Engineering

Tools

Chromatography

Ultra/Diafiltration

SAP

Job description

Site Name: Singapore - Tuas
Posted Date: Jul 22 2024

As a Senior Operations Engineer, you will provide process and technical support to the Manufacturing Operations Teams to enable the Value Stream to meet its operational objectives. Your support will include process optimization, validation activities, continuous improvement, change management, deviation investigation, and production project management to ensure optimal operation and compliance with cGMP requirements.

Key Responsibilities

• Manage deviation investigations and CAPAs related to process or technical events of high complexity.
• Implement changes including eCCs, SMRs, and SAP master data (e.g., BOM).
• Conduct non-process specific training.
• Perform gap analysis against QMS (CQMPs, GGs) and Quality Alerts.
• Prepare documents and training materials to support operations activities.
• Identify, manage, and execute process optimization and operational excellence initiatives.
• Support manufacturing validation, trials, development, and technical transfer activities as needed.

Interface and Management

• Develop relationships within the Value Stream team and with other departments (MSAT, QA, QC, TS) to ensure objectives are met.
• Plan, manage, and execute deliverables efficiently, utilizing resources effectively.
• Coordinate the use of ad-hoc team members, including Engineer Trainees.

Leadership (Senior Engineer)

• Coach and guide Operations Engineers in daily tasks.
• Assist the Senior Operations Executive/Manufacturing Manager in ensuring quality and timely delivery of tasks and projects.

Technology Transfer

• Participate in new technology and process transfers.

Skills, Knowledge, and Experience

Professional:

• Degree in Chemical Engineering or relevant field.
• Minimum 4 years experience in biologics or pharmaceutical manufacturing.

Technical:

• Knowledge of cGMP and biosafety.
• Experience with biotechnology equipment and downstream processes such as Ultra/Diafiltration and Chromatography.
• Equipment troubleshooting and process troubleshooting skills.
• Project management skills and process automation experience.

Business:

• Strong communication and team-building skills.
• Effective organization and project management skills.
• Ability to work independently with problem-solving and analytical skills.

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to combat diseases and improve health worldwide. We focus on vaccines, specialty, and general medicines, investing in innovative platforms and data technologies across core therapeutic areas.

Our success depends on our people. We aim to create an inspiring, inclusive environment where everyone can thrive, grow, and contribute to our mission of getting Ahead Together.