Job Abstract

GSK is currently looking for a Compliance Engineer to join our Team in Rockville, MD The role involves overseeing and verifying that both the engineering department and the entire facility adhere to Engineering, GSK, and regulatory standards. It is essential to maintain technical engineering records accurately while tracking and promptly address any deficiencies.

• ·Own and drive compliance with the Quality Management Systems and Safety systems within Engineering.
• Provide a strong link between Engineering, QA and the Safety department.
• Manage the department Self Inspection Audit/Management Monitoring programme.
• Ensure timely completion of GES / ES GAP Analysis and KPI reporting.
• Co-ordinate with relevant department to track the implementation of CAPA from audit findings in accordance with regulatory and Group requirements. All issues are to be closed promptly for reporting to responsible site coordinator.
• Manage GSK’s Global Engineering Alerts Program and working with stakeholders to ensure comprehensive and timely closure.
• Oversee the non-GxP Change Control procedures.
• Coordinate the risk management program for the engineering department, providing oversight to ensure the department maintains a state of control.

Basic Qualifications:

• Bachelor's degree in engineering, such as process, chemical, electrical, mechanical, or biomedical engineering.
• At least 2 years of experience in Pharma manufacturing environment.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Good Computer Skills (MS Office, MS Projects).
• Familiar with cGxPs.
• Technical understanding of industry / OSHA safety requirements.
• Excellent communication, problem-solving, and analytical skills.
• Ability to work independently and as part of a team.
• Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
• Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams
• Sense of Urgency / Decision making.
• Strong interpersonal skills.
• Must be able to work within a multi-disciplinary team environment. 
• Must be able to generate options to resolve problems, prioritize solutions and implement decisions. Must be competent in handling simultaneously occurring tasks and smaller projects, and have excellent written and oral communication skills.

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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