Engineering Document Control Specialist

S

Sigma-Aldrich Manufacturing LLC

Posted 2 months ago

Full Time

St. Louis, Missouri

In Person

Smart Summary

Responsibilities

The specialist will coordinate the preparation, execution, and filing of validation protocols, maintenance work orders, and calibration certificates. They will also manage the end-to-end calibration cycle and ensure all technical documentation adheres to cGMP and regulatory requirements.

Qualifications

This role requires an Associate's Degree in a life science discipline and at least one year of experience supporting GMP manufacturing. Key responsibilities include coordinating documentation, maintaining quality systems, and managing databases for validation and calibration. Strong computer skills and experience with QMS/CMMS systems are essential.

Job Description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 


Your Role:

In this role responsibilities include but are not limited to:

Essential Job Functions:

  • Coordinate the preparation, execution, scanning, and filing of validation protocols, maintenance work orders, and calibration certificates.
  • Maintain engineering, maintenance, and validation quality systems in strict adherence to cGMP and regulatory requirements such as ICH Q7.
  • Collaborate with Validation Engineers to ensure all technical documentation is accurately completed and archived in designated locations.
  • Develop and maintain specialized databases to track various validation activities, maintenance work orders, and equipment calibration history.
  • Oversee the administration of temperature and humidity monitoring instruments, including tracking locations and managing deployment.
  • Manage the end-to-end calibration cycle, ensuring instruments are sent out on schedule, documentation is verified upon return, and equipment is properly returned to service.
  • Assist in generating comprehensive reports for periodic system reviews and specific validation test cases.
  • Provide essential documentation support for equipment commissioning and qualification, as well as gathering necessary data for internal, customer, and regulatory audits.

Who You Are:

Minimum Qualifications:

  • Associate’s Degree in Chemistry, Biology or other Life Science discipline.
  • 1+ years’ experience supporting a GMP Manufacturing group.
  • 1+ years’ experience in Trackwise, Mango, and SAP or other QMS and CMMS systems.

Preferred Qualifications:

  • Experience working with Validation or Quality teams in a GMP environment.
  • Experience working with cross-functional teams.
  • Strong oral and written communication skills.
  • Experience with good documentation practices.
  • Strong computer and document management skills.

Pay Range for this position: $25/hr - $43/hr​
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

S

Sigma-Aldrich Manufacturing LLC

Together with our colleagues, customers and stakeholders, we impact life and health with science. Before researchers can make scientific breakthroughs, they must have access to state-of-the-art tools, services and expertise to perform experiments and engineer new products. That’s where we come in. We offer one of the broadest portfolios in the industry for scientists, best-in-class products for pharmaceutical development and manufacturing, and a fully integrated service organization to support CDMO and contract testing across traditional and novel modalities. Our vision is a world where our innovative products, services and digital offerings help create solutions for people globally and a sustainable future for generations to come. The life science business of Merck KGaA, Darmstadt, Germany, operates as MilliporeSigma in the US and Canada. Merck KGaA, Darmstadt, Germany is a global science and technology company with around 60,000 employees in more than 66 countries. Intended only for US/CA visitors.
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