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Process Development Engineer Job Opening In San Diego – Now Hiring Hologic, Inc.


Job description

This Process Development Engineer role in the Operations – Process Transfer group requires technical expertise in developing and troubleshooting manufacturing process in NPD and Sustaining, for oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product.

In this role, you will:

  • Lead the development, validation, transfer and implementation of new manufacturing processes;
  • Plan and execute experiments to develop process parameters and / or bring resolution to investigations resulting from non-conformances; and
  • Participate in new product development, scale-up and optimization projects and core teams.
  • This is a fully onsite role based out of San Diego, CA.


    Essential Duties and Responsibilities

  • Serve as subject matter expert (SME) in oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product GMP manufacturing.

  • Troubleshoot complex manufacturing process problems.
  • Define, monitor and analyzes process parameters and data (KPIs and CQAs).

  • Ensure availability of equipment/instrumentation for GMP use.

    This includes coordination of associated IOQs, CCEs, internal maintenance/upkeep, instrumentation troubleshooting documentation, and instrument updates.
  • Research, evaluate and purchase new raw material, instruments and equipment.
  • Utilize root cause analysis to resolve non-conformances.

    Independently generate experiments to obtain root cause.
  • Independently generates notebook studies, development reports, technical reports, development documents and manufacturing documents.

    Reviews validation protocols and reports as appropriate.
  • Plan and execute CAPAs that result from non-conformance investigations.
  • Develop, improve, validate and implements GMP manufacturing processes.
  • Trains personnel in new manufacturing processes.
  • Participates in the transfer of GMP processes to and from other manufacturing sites.
  • Serves as SME oversight for outsourcing manufacturing.
  • May represent department as Core Team or Extended Core Team member as part of New Product Introductions.
  • Required Qualifications and Experience 

  • Minimum of a Bachelor's Degree, preferably in Chemical Engineering, Biomedical Engineering, or relevant fields.

  • Minimum of 5 years of diagnostic product/process development/transfer experience in a regulated environment (Medical Device or Pharmaceutical)
  • Required Skills

  • Knowledge of GMP/GLP
  • Certification in CQE / Six Sigma Green Belt highly preferred
  • Working knowledge of QSR/QMS application
  • Proficiency with MS Word and Excel
  • Strong change control skills and ERP knowledge
  • Ability to analyze data and come to valid scientific conclusions
  • Ability to document technical work and lead investigations and improvements in a GMP environment
  • Good technical writing skills and ability to prepare and present data
  • Ability to work collaboratively with intra and interdepartmental teams.
  • The annualized base salary range for this role is $78,300 to $122,400 and is bonus eligible.

    Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.


    Why Hologic?


    We are committed to making Hologic the company where top talent comes to grow.

    For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

    Required Skill Profession

    Engineers


    • Job Details

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    Unlock Your Process Development Potential: Insight & Career Growth Guide


    Real-time Process Development Jobs Trends (Graphical Representation)

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    38583 Jobs in United States
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    1212 Jobs in San Diego
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    Download Process Development Jobs Trends in San Diego and United States

    Are You Looking for Process Development Engineer Job?

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    The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Hologic, Inc. adheres to the cultural norms as outlined by Expertini.

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    1. Independence

    2. Loyalty

    3. Impartiapty

    4. Integrity

    5. Accountabipty

    6. Respect for human rights

    7. Obeying United States laws and regulations

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    Interview Tips for Process Development Engineer Job Success

    Hologic, Inc. interview tips for Process Development Engineer

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    Before the Interview:

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