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Operations Process Engineer-Scientist 2

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Manufacturing Operations
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The Operations Process Engineer -Scientist 2 supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.    
 
Job Summary
The Operations Process Engineer/Scientist 2 supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.    
 
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 
  • Become a subject matter expert (SME) on multiple manufacturing processes/ products
  • Perform risk assessments for process deviations and Product Response Team in support of Manufacturing
  • Oversees the resolution of manufacturing process issues to ensure on-market product availability.
  • Possesses skills required for communication and collaboration with internal customers to develop/modify manufacturing processes/procedures.
  • Prepares and executes protocols, reports and test plans.  Generates data summaries with complex statistical analysis.
  • Support qualification of new raw materials, container closures, resins, vendors.
  • Supports the development or modification of product specifications.
  • Supports regulatory affairs with technical submissions.
  • Provides SME support in internal/external audits.
  • Performs Design/Risk assessments for change orders.
  • Participates in the development of pFMEAs.
Qualifications
  • Demonstrate strong understanding of chemistry/biochemistry.  NAT experience is a plus.
  • Demonstrate knowledge of process engineering/validation
  • Demonstrates strong peer to peer communication skills.
  • Demonstrates knowledge of and has the ability to apply concepts of statistical analysis
  • Good understanding of design control and risk management.
    Ability to troubleshoot and solve technical issues
    Sound technical writing
  • Ability to work independently with little to no supervision on increasingly complex projects.
  • Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.
  • Good understanding of root cause analysis methods
  • Ability to work in and/or lead cross-functional improvement teams
 
Education and Experience

BS and 6 years or MS and 4 years or PhD and 0-2 years related experience in scientific discipline

 
 
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
 
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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