Principal Process Engineer - Scarborough, United States - Abbott Laboratories

Description

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Principal Process Engineer is within our Technical Product Support, Production and Process Engineering section in the Infectious Disease (ID) business unit located in Scarborough and Westbrook, Maine. This position is responsible for process engineering and technical support of ID Molecular and Lateral flow assays.

The primary function of the position is to lead strategic technical projects acting as team leader and lead investigator. The successful candidate will demonstrate the ability to lead projects and guide technical troubleshooting including design of experiments and statistical data analysis for both rapid molecular diagnostic and lateral flow assays. Strong scientific communication is essential to the role as is the ability to manage long and complex projects. The candidate will drive design changes related to specifications setting, sampling plans, gross margin improvements, process improvements, corrective actions, and process controls. Other primary functions include the identification, review, and assessment of process technologies that could improve manufacturing efficiency and product quality as well as increasing yields and reducing cycle times.

This role will liaise between Systems Engineering, Technical Product Support, R&D, site-level Operations, Quality Assurance, Regulatory Affairs, and outside suppliers/vendors. The ideal candidate will possess a strong scientific/engineering background with excellent communication skills, the desire to direct others to complete tasks/projects, a team-centric attitude, and creative/innovative problem-solving skills. The candidate must be a self-starter with a very high degree of commitment, technical skill, and dedication.

What You'll Work On

• Process engineering, improvement and scale up of reagents manufacturing for Molecular and Lateral Flow assays.
• Leads Design changes starting from design input, identification of critical process parameters, characterization, verification and validation studies, specification setting, protocols/reports and DMR updates.
• Supports technical resolution and review of vendor change notifications and qualification of alternate vendors.
• Designs, executes, and leads others to complete experiments related to the development and implementation of robust manufacturing processes and applies statistical analytical techniques to investigate on-market product performance issues and investigations.
• Leads CAPA root cause investigations using standard investigational techniques, action implementation and effectiveness checks.
• Plays leading role in Audit preparedness and support activities.
• Travels to other manufacturing sites and vendor factories for design reviews and inspection.
• Presents findings to peers and upper- level management and maintains detailed timelines to ensure task completion.
• Facilitates process transfer and training at sites of manufacture.
• Trains lower-level scientists.
• Presents scientific observations at internal technology reviews and external scientific venues.
• Expertise and Problem Solving: Establishes criteria and technical standards for excellence; anticipates, recognizes, and resolves technical problems; identifies new directions for research.
• Responsible for implementing and maintaining the effectiveness of the quality system.

Required Qualifications

• Bachelor's Degree is required.
• Master's Degree or PHD Preferred.
• Up to 15% Travel Required (Including international travel).
• 9 years or more experience in similar with Master's degree.

PREFERRED COMPETENCIES AND EXPERIENCE

• Analytical techniques: Mathematical modeling, Bio-conjugations/Dialysis/Diafiltration/Heat transfer, Oligo synthesis and purification, Bio-conjugation, Realtime PCR, Bio-purification, Immunoassays, Molecular assays, Lateral flow assays, Polymerization, Lyophilization and Drying, HPLC, Statistical quality control, Polyacrylamide gel electrophoresis, Microfiltration, Ultrafiltration, Recombinant DNA technology, Quartz crystal microbalance, Dynamic light scattering, FMEA, Hazards analysis and Hazards operations
• 6+ years in the Biotechnology industry with a significant focus in research and development, process design and development, and/or operations/design change control plus PHD in related field of study.
• PhD in Chemical Engineering, Biotechnology or similar
• Expertise in statistical data analysis, R, JMP, SPC and DOE methodology.
• Proven track record of technical project management/oversight of strategic multi-year projects.
• Prior experience in molecular diagnostics, immunoassays, ELISA-based assays, and/or immunochromatographic devices.
• CAPA root cause investigations using standard investigational techniques, action implementation and effectiveness checks.
• Candidates should work well in a team environment and have flexibility to work on rapidly changing priorities.

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is $95,000.00 – $190, In specific locations, the pay range may vary from the range posted.