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GMP Engineering and Maintenance Compliance Associate
Posted 05 Apr 2023
St. Louis, Missouri - United States
Req Id 262930
Work Your Magic with us!
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.
MilliporeSigma has an exciting opening at their Cherokee/St. Louis site. The Engineering and Maintenance Compliance Specialist's primary role is to provide support to the cGMP operations. This position will be responsible for assisting Engineering, Manufacturing, Technical Operations, and QA with quality support as it relates to change control, equipment non-conformances, process deviations, routine equipment system maintenance and Building Management System support. Additional responsibilities may include on the floor oversight during manufacturing, incident investigations and resolution, monitoring of the building management system.
- Coordinate documentation and tasks associated with equipment and facilities:
- Change management
- Addition of new equipment
- Preventative maintenance and Calibration
- Non-Conformances and CAPAs
- Work with Engineering, Technical Operations, Maintenance, Manufacturing, Validation, and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved, and implemented
- Assist with equipment and facility investigations, troubleshooting, and root cause analysis
- Support with the management of preventative maintenance tasks, change control, and equipment/facility shut-down activities:
- Perform updates to CMMS in compliance with cGMP
- Generate, review and close work orders as needed in CMMS
- Assist with equipment and facility risk assessments and mitigation
- Ensure planned and unplanned work is prioritized and managed closely to minimize disruptions to Operations' schedule
- Maintenance of quality systems and cGMP compliance for Engineering and Maintenance
- Ability to understand regulatory requirements such as ICH Q7
- Support equipment commissioning, qualification, and validation activities related to GMP manufacturing
- Create new assets and spare parts in CMMS
- Write, review and/or assist in the development of Facility and Equipment Operating Procedures
- Assist with internal, customer, and regulatory audits
- Write Engineering CAPA, deviation, and change control trend reports
- Write Quarterly alarm trending reports
- Drive continuous improvement to Engineering and maintenance practices to support customer and regulatory expectations
Who You Are:
- Associate degree in a technical field
- 1+ years of experience working/supporting a GMP Manufacturing group
- Bachelor’s degree in Engineering
- 1+ years of experience in equipment systems administration
- 1+ years of pharmaceutical industry work experience
- Experienced in Trackwise, Mango, and SAP or other QMS and CMMS system specifically in the Quality Management and Engineering systems
- Strong computer, document management and attention to detail
- Demonstrated ability to work within a cross-functional team
- Effective oral and written communication skills
- Effective Good Documentation Practices and communication skills
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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