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 / GLPCertification in CQE / Six Sigma Green Belt highly preferredWorking knowledge of QSR / QMS applicationProficiency with MS Word and ExcelStrong change control skills and ERP knowledgeAbility to analyze data and come to valid scientific conclusionsAbility to document technical work and lead investigations and improvements in a GMP environmentGood technical writing skills and ability to prepare and present dataAbility 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.
