Principal Project Engineer - Reagent Chemist
Company: Joule
Location: Brookline
Posted on: June 17, 2022
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Job Description:
Title: Principal Project Engineer- Reagent Chemist
Location: Boston, MA
Schedule: Mon-Fri 8AM-5PM
Type: Direct Hire
Start date: ASAP
Responsibilities:3 main responsibilities for this role. Tech
contributor to chemical reagent strategy; working closely with
supply chain and where the materials are acquired from, Bridging
new reagents into production; working closely with scientific group
as they develop new reagents helping from scale to a manufacturing
level, Developing out biologics materials; for the tank system will
work with external vendors to bring it to commercial level
Working together with the operations and supply chain
organizations, this role will have technical ownership of our
overall reagent and chemical supply strategy. This will include
assessment of vendors and the development and execution of
qualification strategies
Contribute to the development of novel reagents and ensure they are
ready for transfer to manufacturing processes
Lead the development of biologic control systems for use in
in-vitro diagnostics
Provides technical support to manufacturing and quality
organizations to aid in the troubleshooting of reagent based
non-conformities and corrective actions
Demonstrates deep/advanced knowledge of specialized discipline and
methods, and applicability to specialized product needs to support
customer, operational policies and processes. Interfaces with
customers, suppliers, application users, and other technical and
support personnel as necessary
Develops complex test protocols; reviews, and rejects or approves
test protocols developed by others, documents/reports findings, and
provides corrective guidance
Requirements:BS in a relevant Engineering discipline such as
Biomedical, Chemical, Mechanical or equivalent required
10 years hands-on technical experience developing complex /
multidisciplinary reagent systems for in-vitro diagnostics
required
10 years experience with medical device / IVD development under FDA
Quality Systems Regulations, CE Marking, and ISO Quality Systems
required
5 years experience with hemostasis based diagnostic and reagent
systems preferred
3 years proven technical leadership over the development of a
complex / multi-disciplinary product in a regulated environment
required
Joule, a System One division is a leader in specialized workforce
solutions and integrated services. With more than 6,000 employees
and roughly 50 offices throughout the U.S. we provide scientific,
clinical, engineering, energy, IT, legal and administrative
staffing services. For more than 40 years, we have delivered
workforce solutions and integrated services to clients
nationally.
Keywords: Joule, Brookline , Principal Project Engineer - Reagent Chemist, Engineering , Brookline, Massachusetts
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