Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Process Engineer (Drug Product/Medical Device Combination)

Employer
Abbott Laboratories
Location
Sylmar, CA
Salary
Up to $125,000 and benefits
Start date
May 17, 2019

View more

A successful candidate will have polymer based drug product and/or drug/device combination, and manufacturing experience.  The candidate will be responsible for multiple projects associated with process development, identifying and qualifying process equipment for new product introduction, and troubleshooting of combination products and cardiac implantable devices. The position will play a key role in planning and executing our Development and Operations strategy required to support new product approvals and to meet legacy product regulatory commitments. This position will work across the organization driving and collaborating with functions in Development, Operation, Quality and Regulatory to assure the successful execution of our business goals. 

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. Today, more than 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Impact this role will have on Abbott:

Process Engineering:

  • Coordinate and lead commercial drug product manufacturing operations with technical evaluation of NCMR/CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection) and reserve samples (creation, storage, and testing).
  • Lead regulatory filings and inspections.
  • Troubleshoot issues with drug product processing technologies and equipment.

New Product Introduction:

  • Lead process development and provide training to manufacturing operators and junior colleagues for polymer-small molecule based sterile commercial drug product processing in specific areas such as formulation development, process characterization, sterile processing, tech transfer, validation and drug product manufacturing.
  • Experience with injection molding process development and process validations in medical device /Pharmaceutical industry; ability to trouble shoot technical issues related to injection molding process a plus.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, Company policies, operating procedures, processes, and task assignments.  Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Coordinate and manage multiple transfers of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine clinical and/or commercial production.
  • Coordinate and manage multiple NPI programs, drive schedules and ensure deliverable are met
  • Provide customer interface during the design, development and manufacture of the NPI products

Process Performance:

  • Projects involve leading collaborating with cross-functional teams developing test plans, leading root cause analysis and participating in investigations.  Also making presentations to internal/external customers, vendors, and senior management
  • Develop, plan and track risk assessment for drug product operations non conformances, change controls, and implements appropriate CAPAs. Lead process modelling, data trending and advanced statistical & process analysis – present data/metrics to teams.
  • Implement process improvement strategies to improve quality, reliability and/or reduce cost.
  • Manage Internal and External suppliers design, manufacturing and qualification activities.

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • BS/ MS/Ph.D. in Chemical/Biochemical Engineering, Polymer Engineering, Mechanical Engineering, Biomedical Engineering, or Science .
  • Bachelor's Degree with 7 + years of Process Engineering or Operations experience OR a Master's Degree with 5+ years of Process Engineering OR Operations experience, Ph.D degree with 3+ years of Engineering or Operations experience.
  • Process/equipment development and optimization experience in small drug molecules and polymers based drug delivery systems.
  • Experience in project management including the ability to manage multiple projects, strategically prioritize activities and leading cross functional teams within Operations/Manufacturing.
  • Proven track record of successful collaboration and leadership to cross-functional teams to advance complex projects to completion. Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.
  • Process/equipment development and optimization experience with late stage or commercial products.
  • Strong knowledge of Quality systems, drug product manufacturing and validation. 
  • Work history with cGMPs, regulatory filings and compliance issues for combination devices.
  • Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert