Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

We have an opportunity for Process Engineer II based in San Diego, CA. In this role, the person will be expected to apply process engineering knowledge in support of technology transfer to clinical and commercial manufacturing at Abbott. In addition, they will also provide dedicated process engineering support for human implantable products in clinical development through commercial production.

WHAT YOU’LL DO

• Process Engineering:
  • Support 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).
  • Support of regulatory filings and inspections.
  • Troubleshoot issues with drug product processing technologies and equipment. Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

• New Product Introduction:
  • Provide process development expertise for polymer-small molecule sterile drug product processing in specific areas such as formulation development, process characterization, sterile processing, tech transfer, validation and drug product manufacturing.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, company policies, operating procedures, processes, and task assignments.
  • Transfer 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.
  • Ensure that qualification parameters and process validation are complete for drug product-Medical Device assembly requirements.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Process Performance:
  • Projects involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management
  • Conduct risk assessment for drug product operations non conformances, change controls, and implement 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.
  • Minimal domestic and international travel as needed.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor's Degree 3-5 years of Process Engineering or Operations experience OR a Master's Degree + 3 years of Process Engineering or Operations experience.
• Process/equipment development and optimization experience in small drug molecules and polymers based drug delivery systems.
• Knowledge of late stage or commercial products experience with strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
• Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices. Excellent interpersonal and communication skills with the capability to work with global audiences such as senior executives, fellow employees and external agency partners.
• 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.
• Have drug product and/or drug/device combination process development and manufacturing experience.

WHAT WE OFFER

• At Abbott, you can have a good job that can grow into a great career. We offer:
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$79,500.00 – $138,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Engineering

     

DIVISION:

CMI ARDx Cardiometabolic and Informatics

        

LOCATION:

United States > San Diego : 9940 Mesa Rim Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf