Engineering Compliance Specialist
Millipore Corporation

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.

The Engineering 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 including all maintenance change plans and change orders
• Addition of new equipment into our CMMS including creation of calibration and PM documentation
• Preventative maintenance and Calibration
• Managing all facilities and maintenance Non-Conformances, CAPAs and Deviation
• Work with Engineering, Technical Operations, Maintenance, Manufacturing, Validation, and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved, and implemented as appropriate
• Assist with equipment and facility investigations, trouble-shooting, and root cause analysis
• Assist with the management of preventative maintenance tasks, change control, and
  equipment/facility shut-down activities
• Assist with equipment and facility risk assessments
• Ensure planned and unplanned work is prioritized and managed closely to minimize
  disruptions to Operations' schedule
• Maintenance of quality systems and cGMP compliance
• Ability to understand regulatory requirements such as ICH Q7
• Supports equipment commissioning, qualification and validation activities related to GMP
  manufacturing
• Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
• Assist with customer and regulatory audits
• Assist in the generation of Engineering CAPA, deviation, and change control trend reports
• Drive continuous improvement to support customer and regulatory expectations

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Engineering, Chemistry, Biochemistry, or other Life Science field of study

• 1+ years of experience supporting a GMP Manufacturing group.

Preferred Qualifications:

• 2+ years of experience in equipment systems administration preferred
• Thorough understanding of Trackwise or SAP, specifically the Quality Management and Engineering Change Control Modules
• Strong computer, document management and attention to detail
• Demonstrated ability to work within a cross-functional team
• Effective oral and written communication skills
• Effective, disciplined, and demonstrated documentation 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

This job has expired.