Compliance Engineer/Senior Compliance Engineer

Posted:
8/27/2024, 8:15:14 AM

Location(s):
Michigan, United States ⋅ Detroit, Michigan, United States

Experience Level(s):
Expert or higher ⋅ Senior

Field(s):
Legal & Compliance

Are you looking for an opportunity to enhance your engineering compliance expertise within a cutting edge global environment?  If so, this Compliance Engineer role could be an ideal opportunity to explore.

As Compliance Engineer, you will be responsible for effectively managing change, identifying and mitigating risks, and ensuring critical control parameters are built into the site standard work and quality critical attributes are continuously monitored.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Lead the identification and implementation of projects/initiatives in order to achieve compliance to GSK Engineering standards, EHS standards and Sustainability initiatives .
  • Provide technical support for facilities infrastructure including but not limited to: HVAC, Clean Steam, Compressed Air (GMP and non-GMP), 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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • HS diploma AND a minimum of 15 years of experience as an HVAC or utilities technician

OR

  • Bachelor's in an Engineering or science field
  • Minimum of 2 years of engineering experience in a pharmaceutical or other GMP environmen

Preferred Qualifications:

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

  • Familiarity with Good Manufacturing Practices
  • Demonstrated ability to generate options to resolve problems, prioritize solutions, determine appropriate course of action, gain consensus on that recommendation, and implement decisions.
  • Must have demonstrated self-direct work habits along with verbal and written communication skills.
  • Must be a committed team player prepared to work in and embrace a team based culture.
  • Able to maintain attention to detail while executing multiple tasks.
  • Able to perform job duties with minimal supervision.
  • Must operate cross-functionally and be able to lead in a matrix organization.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Sense of urgency, flexibility and accountability.
  • Stay current on developments in the field and GSK-Eng Standards.

We are also looking for more experienced individuals for our Senior Compliance Engineer role. The qualifications for this role at our site are listed out below:

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in Engineering or science field
  • Minimum of 5 years of engineering experience in a pharmaceutical or other GMP environment.

Preferred Qualifications:

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

  • Post Graduate Degree.
  • Demonstrated effective management of capital project delivery on time and within budget.
  • Strong technical writing skills
  • Strong project management skills

#LI-GSK

#mariettavaccines

#globalsupplychain

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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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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