Compliance/ Equipment Commissioning Engineer

Engineers in this category are expected to be responsible and accountable for ensuring existing/new systems comply to Engineering Standards, commissioning and qualification of new/modified systems. Role-related competencies and technical skills are necessary for their success. Coupled with an attitude to learn and an analytical mind for problem solving, these engineers must possess the right technical knowledge to provide engineering or technical support to minimize equipment downtime and maximize system performance and ensure reliability.

Project:

Support organization operations on CAPA projects / engineering change modification execution to meet users' requirement.

• Collaborate with cross functional departments on CAPEX projects or change modification (SMR/RPC) implementation.
• Work with contractors / external service providers for performance to meet project delivery.
• Execute IQ & OQ phases of new projects and ensure proper hand over of completed project's documents and drawings.
• Provide support in submission and obtaining the approval of required local permits / licence for new engineering project / modification installation.

Compliance:

Ensure the site is in compliance to Engineering Standard

• Establish ES Review Meetings. Schedule periodic meetings with stakeholders and SMEs to review ES updates, discuss site gaps, and track progress on compliance actions.
• Liaise with Global SMEs to seek clarifications on ES requirements and share responses with site stakeholders for consistency.
• Review Draft ES Comments. Ensure timely submission of comments on draft ES, track responses, and document final resolutions.
• Track CAPAs from Gap Analysis. Initiate CAPAs for identified gaps, assign owners and timelines, monitor progress, and verify closure with documented evidence.

Quality:

• Familiar with Global SOP, Local SOP, Good Engineering Practice, cGMP to maintain quality standards.
• Ensure proper good documentation and record system to ensure quality assurance operations.
• Ensure audit readiness by complying with effective standards, regulatory / statutory; GEP, GDP and cGMP requirement.
• Ensure all work activities are carried out according to site procedures and standards.

Management:

• Ensure cost effectiveness of all tasks and projects.
• Engagement with external service providers and collaborate with cross functional teams.

Safety:

• Maintain safe and clean working environment by establishing and enforcing procedures, rules and regulations for all activities.
• Comply with site and global EHS and Biosafety procedures.
• All work activities are carried out safely and good housekeeping is maintained.
• Ensure external service providers / contractors comply with the site safety rules and regulatory requirement.

Continuous Improvement:

• Contribute to continuous improvement by providing recommendation and initiative to promote sustainability.
• Actively seek improvements to facilities, systems and processes through continuous improvement, streamlining and simplification

Others:

• Accept full ownership of personal responsibility but also work together as an integrated team.
• Any other duties as assign by the supervisor

Basic Qualifications:

• Degree in Chemical Engineering
• 5 to 10 years of project and process engineering experience preferably
• Familiarity with Good Engineering Practices (GEP) and Good Manufacturing Practices (GMP).
• Strong problem-solving skills and attention to detail.
• Excellent communication and teamwork abilities.

Preferred Qualifications:

• Experience in the pharmaceutical or manufacturing industry.
• Knowledge of validation processes, including Installation Qualification (IQ) and Operational Qualification (OQ).
• Ability to manage multiple tasks and adapt to changing priorities.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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