Compliance Engineer/Senior Compliance Engineer

4 days ago


Marietta, Minnesota, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Compliance Engineer/Senior Compliance Engineer to join our team at GlaxoSmithKline. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Manage change and identify/mitigate risks to ensure compliance with GSK Engineering standards, EHS standards, and Sustainability initiatives.
  • Provide technical support for facilities infrastructure, including HVAC, Clean Steam, Compressed Air, Nitrogen, potable and clean water systems, Boiler, and wastewater treatment.
  • Knowledgeable with cGMP and EHS requirements, engineering guidelines, area classifications, and environmental conditions required for Aseptic Manufacturing Facilities.
  • Provide technical support and troubleshooting expertise to correct problems with equipment and associated control systems.
  • Proactively analyze equipment design, repair, and maintenance to address weaknesses and identify opportunities for improvement.
  • Ensure engineering alerts and corporate initiatives are addressed to meet established timelines by working with subject matter experts.
  • Participate in cross-functional teams to implement effective solutions, both at the site level and to support corporate initiatives/projects.
  • Author, review, revise, or approve Standard Operating Procedures (SOP's) as required and provide technical expertise during regulatory audits.
  • Perform risk assessments, manage change through the appropriate change control process, and support Quality/EHS investigations.
  • Support site sustainability initiatives/projects.
  • Develop job safety assessments for high-risk engineering activities.
Requirements
  • Bachelor's degree in Engineering or science field.
  • Minimum of 5 years of engineering experience in a pharmaceutical or other GMP environment.
  • Post Graduate Degree.
  • Demonstrated effective management of capital project delivery on time and within budget.
  • Strong technical writing skills.
  • Strong project management skills.
Why GSK?

At GlaxoSmithKline, we are committed to uniting science, technology, and talent to get ahead of disease together. We are a global biopharma company with a special purpose - to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

We are an equal opportunities employer and adhere to Affirmative Action principles. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).



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