BD (Becton, Dickinson and Company) Sr. Process Engineer - Sterilization Synergy Projects in Covington, Georgia
Job ID: 2018-11686
Career Level: experienced
Division: Bard Medical
Location: Covington,Georgia,United States
The Sr. Process Engineer-Sterilization Synergy Projects is located at BD Covington Operations in Covington, GA.
Summary of Position with General Responsibilities:
This position is responsible for technical execution of activities associated with synergy projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership. Accountable for assigned project technical writing of protocols, execution of study activities, data analysis and reporting to ensure delivery of synergy commitments within defined success criteria.
Essential job Functions:
Key role in execution of the sterilization synergy projects for technical inputs and requirements to ensure meeting the synergy targets as well as allowing current technical resources to support the ongoing business demand. Supports strategic initiatives related to sterilization strategy (network/process optimization, validation, technology, cost). Enable delivery of $10M in synergy over 2.5 years.
Reponsible for technical writing and data analysis for study protocols and reports for projects associated with the BD Sterilization Strategy.
Responsible for working with global sterilization, facilities QA/Ops and regional sterilization resources to obtain required smaples for validation testing and submittion to the laboratory to support synergy projects. Review and approve validation study results and documetnation.
Responsible for workign with global sterilization, facility quality/opos, supply chain and retional sterilization resources to assist with development of project charters, quality plans, quality agreements, and other relevant documents.
Provide assistance with preparation and/or provide technical information to complete ACR submissions and assist with regulator filings.
May perform other duties as assigned.
BS/BA in engineering, science or related field
ASQ CQE (preferred)
3+ years in medical device sterility assurance, sterilization operations or testing environment
In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide, Radiation, Dry Head and Moist Head sterilization)
Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.) and industry standards (ISO/AAMI, etc) related to sterilization validation and routine control.
Knowledge of tools and techniques specific to data analysis, validation execution, process controls and risk management
Broad knowledge of medical device sterilization including but not limited to: sterilization technology, validation (IQ/OQ/PQ), supply chain/logistics, contracting relationships and continuous improvement
Strong math skills, technical writing skills
Strong use of Excel spreadsheets and sterilization data interpretation skills
Organized to manage competing priorities
Ability to understand and translate complex technical requirements into clear actions for execution
Strong written/verbal communication skills to relay technical concepts and study requirements to non-expert stakeholders
Additional Desirable Qualifications Skills and Knowledge:
Must be able to read and comprehend simple instructions in Basic English and write project justification documentation, correspondence / memos email. Must be able to effectively present information in one-on-one and small group situations to staff, internal customers and other employees within the organization.
Ability to apply mathematical concepts such as geometry, trigonometry, exponents, etc. Ability to apply mathematical operations to tasks such as facility design, process line location and layout. Skills necessary to specify and organize performance metrics to measure and evaluate process/cost performance improvement opportunities. Ability to determine, propose and articulate such improvement opportunities to peers and management. Finally to demonstrate end results of such opportunities.
Position requires good logic and reasoning ability. Ability to define problems and find logical solutions. Ability to interpret specifications and technical instructions. In summary, position requires a high degree of logical analyzing. Errors in the facility or process design bring heavy liability and financial burden to the Company. Errors in safety equipment could bring loss of life. Position interfaces heavily with outside
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status