A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMérieux's global headquarters is located in Marcy L'Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.
The Manufacturing Compliance Engineer will focus on Right First Time (RFT) initiatives
Review of manufacturing documentation for compliance to GDP and CPP prior to submission to QA
Provide on the floor document review, track and trend RFT metrics,
Evaluate trend data for process improvement
Deliver training to manufacturing teams on SOP/Process changes
Execute document and process improvement changes
Track training to maintain compliance
Support Right First Time initiatives as assigned
Perform review of Manufacturing Documentation across multiple production lines
Ensure all Manufacturing Documents are fully reviewed before submission to the Batch Release Group
Provide on the floor document review and recommendations for error corrections
Support manufacturing teams to provide feedback on error trends and area of focus
Record and maintain data to track batch record turnaround time, errors and document related deviations
Track training activities and curriculums to ensure compliance is consistently maintained
Partner with Training, Industrialization, Engineering and Manufacturing departments to provide detailed training on SOP and process changes to ensure compliance
Provide improvement ideas on documentation and processes
Complete change control to ensure that improvement ideas are fully implemented.
Partner with the investigation team to promote timely correction and closure of Non-Conformances
Perform any additional job related duties as requested
Studies/Experience, Skills and Qualifications:
Bachelor's Degree OR 8 years of relevant experience required
Experience in FDA regulated environment with knowledge of Good Manufacturing Practices
Experience in Batch Record review preferred
Experience in delivering training preferred
Knowledge of Microsoft Word, Excel, PowerPoint and Outlook required.
SAP experience preferred
Quality documentation review in production facility preferred Excellent interpersonal skills and ability to work with all levels of an organization
Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
Must be able to work effectively in a team based and individual environment.
Must hold to the highest level of accountability and integrity
Must be able to deliver negative and positive feedback effectively.
Leadership experience preferred
Strong analytical and problem-solving skills.
Ability to translate written instructions, work orders and specifications.
A minimum of 5 years in a GMP production/operations environment
Demonstrated detailed knowledge and/or ability to understand mechanical systems and manufacturing processes
Ability to regularly climb stairs to perform work
Ability to work overtime as required to support a 24/7 production operation
May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials
May be exposed to strong odors incurred during media production or other operations
May be required to wear various types of PPE & cGMP which includes but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA