Staff Process Engineer
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Staff Process Engineer NPD R&DBiosurgery
Location :1000 US-202 Raritan NJ 08869
Location :1000 US-202 Raritan NJ 08869
Long Term Contract
Job Description:
The Staff Process Engineer Biosurgery R&D (Process Development) will be working with
a multidisciplinary team of scientists and engineers in the discovery and development of
differentiated and ownable hemostats and sealants solutions to address important
unmet surgical needs.
Key Responsibilities:
Lead R&D process development activities for hemostats sealants adhesion prevention and other surgical products aligned with strategic priorities.
Author and lead creation of work instructions build protocols/reports and IQ/OQ/PQ and FAT documentation in collaboration with cross-functional stakeholders for GLP and clean room processes.
Engage with external equipment vendors to identify and implement advanced technologies; plan conduct and support trials at vendor sites.
Create maintain and close capital appropriation requests and POs related to equipment purchases and vendor services.
Specify procure and qualify new equipment in compliance with GLP and ISO 8 clean room requirements.
Design experiments and execute activities such as equipment selection and specification development process validation process capability and FMEA.
Collaborate in cross-functional/multidisciplinary teams such as Clinical Regulatory Quality Supply Chain etc.
Incorporate manufacturability into your research to partner with manufacturing in the scale-up of R&D concepts and processes to full production scale.
Perform hands-on laboratory development analyze and interpret data document research findings and manage multiple concurrent projects.
Qualifications
Education and Required Experience:
Bachelors degree in Chemical Engineering Materials Science or related field required. An advanced degree (M.S. or Ph.D.) is preferred.
Minimum of 10 years of process development experience in a medical device or pharmaceutical industry environment.
Experience with powder and sheet handling drying and powder dosing (auger- based dosing equipment).
Experience with supporting teams that successfully launched a product onto the market.
Strong understanding of IQ OQ and PQ documentation and execution in clean room settings.
Strong experience with DOE design execution and data analysis.
Familiarity with GLP laboratory and clean room practices including equipment and room cleaning documentation.
Familiar with capital purchase process and PO processing by interacting with equipment vendors.
Experience with scale up and technology transfer to commercial manufacturing is preferred.
Knowledge of and experience in applying scientific principles analytical techniques and judgment to independently resolve technical issues and
establish new methods controls and procedures is required.
Demonstrated ability to independently design carry out experiments and interpret results is required.
Experience with supporting teams that successfully launched a product onto the market.
Strong understanding of IQ OQ and PQ documentation and execution in clean room settings.
Strong experience with DOE design execution and data analysis.
Familiarity with GLP laboratory and clean room practices including equipment and room cleaning documentation.
Familiar with capital purchase process and PO processing by interacting with equipment vendors.
Experience with scale up and technology transfer to commercial manufacturing is preferred.
Knowledge of and experience in applying scientific principles analytical techniques and judgment to independently resolve technical issues and
establish new methods controls and procedures is required.
Demonstrated ability to independently design carry out experiments and interpret results is required.
Other:
Excellent verbal and written communication skills.
Highly organized detailoriented and selfmotivated.
Strong analytical problemsolving and interpersonal skills.
Displays passion and enthusiasm for innovation.
Strong analytical and problem-solving skills.
Superior interpersonal skills to collaborate with internal and external business partners across functional teams.
Ability to travel domestically and internationally up to 15%.
Excellent verbal and written communication skills.
Highly organized detailoriented and selfmotivated.
Strong analytical problemsolving and interpersonal skills.
Displays passion and enthusiasm for innovation.
Strong analytical and problem-solving skills.
Superior interpersonal skills to collaborate with internal and external business partners across functional teams.
Ability to travel domestically and internationally up to 15%.
