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Process Development Engineer 2

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Manufacturing Operations
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276 Total Views
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
 
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
 
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
 
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
 
Job Summary
This Process Development Engineer 2 role in the Operations – Process Transfer group requires technical expertise in the manufacturing process of oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, final formulations and/or lyophilized finish product.  Provides process support to Operations through troubleshooting issues related to production processes, analytical/in-process instrumentation, and raw material.  The Process Development Engineer 2 will plan and execute experiments to bring resolution to investigations resulting from non-conformances.  Leads the development, validation, transfer and implementation of new manufacturing processes.  May participate in new product development, scale-up and optimization projects.
 
Essential Duties and Responsibilities
  • Serves as subject matter expert (SME) in oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, final formulations and/or lyophilized finish product GMP manufacturing.  
  • Troubleshoots complex manufacturing process problems.
  • Monitors and analyzes process data (KPIs and CQAs). 
  • Ensures availability of equipment/instrumentation for GMP use.  This includes coordination of associated IOQs, CCEs, internal maintenance/upkeep, instrumentation troubleshooting documentation, and instrument updates.
  • Researches, evaluates and purchases new raw material, instruments and equipment.
  • Utilizes root cause analysis to resolve non-conformances. Independently generates experiments to obtain root cause.
  • Authors investigations, SOPs, validation protocols and reports.
  • Plan and execute CAPAs that result from non-conformance investigations.
  • Develops, improves, validates and implements GMP manufacturing processes.
  • Trains personnel in new manufacturing processes.
  • Independently generates notebook studies, development reports, technical reports, development documents and manufacturing documents.
  • 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.
 
Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
  • May lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight
  • Exposure to hazardous chemicals
Qualifications:
Education       
Minimum of a bachelors’ degree in engineering, biological sciences, chemistry or genetics.
 
Experience     
Minimum of 5 years of diagnostic product/process development/ transfer experience.
 
Skills  
  • Working knowledge of QSR/GMP
  • Knowledge of GMP/GLP
  • Proficiency with MS Word and Excel
  • Strong math skills
  • Strong EDMS 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.
 
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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