Abbott Senior Engineer, Process Development in Plano, Texas
At Abbott, we're committed to helping people live their 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 -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Process Engineering technical expert to lead process development engineering projects including the design and development of manufacturing processes, documentation, and equipment to successfully transition new products from design to manufacturing while enhancing productivity.
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.
Process development team is facilitating an aggressive, innovative pipeline of new products over the next several years by developing revolutionary processes and technologies supporting Abbott’s rapidly growing NM business
Process development fills the critical technological chasm between idea conception and manufacturing execution for delivering new products to market
Process development team investigates and applies cutting edge technology and processes to differentiate our NM business providing a competitive advantage
New Product Introduction:
Provide process development expertise and training to manufacturing operators and junior colleagues for commercial drug product processing in specific areas such as injection molding, drug product molding, drug product manufacturing principles, reserve samples, sterile processing, process characterization, tech transfer and Validation.
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 legacy and NPI products
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.
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.
Good understanding of statistical tools such as DOE, process capability analysis, Gage R&R, etc.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
BS in Engineering or equivalent technical field; advanced degree preferred
6+ years manufacturing experience, with 3 years of people management experience
Prior experience in medical device / FDA regulated manufacturing preferred
Experience leading new production introductions and associated process development
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.
Expertise with statistical techniques (e.g., DOE, SPC)
Demonstrated skills to forge strong, collaborative business relationships to help and organization exceed its objectives
Process/equipment development and optimization experience
Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
Aptitude to effectively manage multiple competing priorities in a fast-paced, changing environment
Strong verbal and written communications with experience effectively communicating to multiple levels in the organization.
Strong organizational, planning, and follow-up skills and ability to hold others accountable
Ability to travel approximately 10%, including internationally
Experience with CAD
Experience with equipment systems, PM’s, and calibration
TPM experience preferred
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com