Process and Facility Engineer

Laboratory Opportunities
Job Function/Requirements: 
  • Provide a high level of customer service
  • Insure customer satisfaction with timely, efficient and accurate service
  • Provide administrative assistance
Essential Job Duties: 
  • Ensure comprehensive Preventative Maintenance program, Validation Master Plan, other validation documents and activities are continuously maintained, to assure a state of continuous readiness to audit/inspection
  • Ensure all calibration, validation and qualification activities of products, processes, methods, facilities, utilities and equipment comply with internal requirements and applicable regulations and standards
  • Provide leadership and support to Technology Transfer, Manufacturing and Quality Laboratory functions to ensure that new processes and changes to existing processes are developed in compliance while adhering to approved project targets such as budget and timelines.  The ability to be creative and flexible while maintaining compliance will be critical to success in this position
  • Assist in the development, approval, and change control of manufacturing, testing procedures and development related documentation (e.g. Design Inputs, Design Outputs, Calibration, Verification/Validation, Change Impact Assessments, Work Instructions, Protocols, Reports, etc.).
  • Conduct effective and timely investigations related to process and system deviations, failure/complaints trends.
  • Ensure effective time and task management in scheduling and performance of, as well as management of internal/external support personnel related to Preventative Maintenance, Calibration, Qualification, Verification/Validation activities, to prevent disruption and/or delay of manufacturing, laboratory and business activities and operations. Off hour and/or weekend work may occasionally be required.
  • Lead cross-functional teams in process and systems review, continuous improvement, Statistical Process Analysis and value stream mapping projects.
  • Develop and conduct effective training on Process Capability/Stability Analysis, Process Control, Calibration, Qualification, Verification/Validation and other topics as needed.
Nature and Scope: 
  • Provide status updates, reports and recommendations for improvement to management.
  • Develop and maintain comprehensive preventative maintenance, calibration, qualification, verification/validation systems, protocols and reports, ensuring accuracy, compliance and constant state of readiness for audits and regulatory inspection.
  • Ensure deviations, investigations, audit action items, change control status, and corrective/preventative actions at site are appropriately closed in a timely manner.
  • Ensure site master documents are continuously maintained current and accurate.
  • Provide training, guidance, leadership and expertise to personnel through application of quality methods, statistical tools, trend analysis, defining and implementing system and process improvements according to schedule in support of efficient and effective Site operations and Merial standards.
  • He/she must act within the guidelines established by company policy and delegated authority
  • Accountable for complying with the Sanofi/Merial/Newport Business Code of Ethics to the highest standards
  • Accountable for complying with the Company Handbook and all policies set by the Company
  • Minimum of BA/BS Degree in an Engineering/Science field, with Master’s Degree strongly preferred.
  • At least 5 years’ experience related to systems and process design and engineering. Preventative Maintenance, Calibration and Validation is expected.
  • Experience to include increasing responsibility in development, conduct and oversight of validation, process/method optimization and process analysis and improvement.
  • Experience in development and use of Quality tools such as: FMEA risk assessments, design control analysis, SPC, DMAIC, Root Cause, Six Sigma and Value Stream Mapping.
  • Understanding and knowledge of a broad set of regulations and standards (USPA, FDA, CFIA, etc.)
  • Ability to anticipate problems, investigate and identify solutions in a variety of situations.
  • Experience in assembling, managing and leading effective multi-disciplinary teams.
  • Proficiency with Microsoft Office applications and statistical tools.
  • Experience related to quality control, quality assurance with exposure to GMP environment is preferred.
  • Competencies with Microsoft Office Suite applications as well as Adobe Suite and other database applications if intermediate to advanced level is highly desirable
This position offers a competitive salary and full benefit package. Qualified applicants that are committed to be a team member in an innovative culture may submit their resume along with salary requirements

Newport Laboratories, located in Worthington, Minnesota assists veterinarians and livestock producers in their efforts to address animal health problems through diagnostic testing and production of veterinary biologics. We are the nation’s leading manufacturer of autogenous biologics.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.