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Senior Process Engineer - Coventry, United States - Pharmaron Beijing Co. Ltd.
1 month ago
Description
Come Join Our Growing TeamWe are looking for a
Senior Process Engineer
to join our dynamic and growing team in Coventry, RI
Position Summary:
This position within the Manufacturing Technology Team has the responsibility to design, install, and implement processes and equipment supporting GMP production of small molecule active pharmaceutical ingredients (APIs) in a safe, compliant, and efficient manne
r.
Principal Accountabilities:
The Sr.
Process Engineer must apply a broad range of safety, environmental, GMP, engineering, leadership and technical skills across a broad range of issues.
Critical to the success of this position is adherence to cGMP and OSHA Process Safety Management regulations, development of robust, reliable production processes, and cost-effective installation of durable, multi-purpose (flexible) chemical and solids processing equipment.
The responsibilities of the SrProcess Engineer include:
Support technical transfer of new processes from concept through product delivery, including
Define scale and equipment fit of new processes within existing facility
Design and install new equipment and/or existing equipment modifications to support new process requirements
Manage process safety concerns with accountability for PSM implementation using existing Coventry procedures (thermal hazards, relief design, PHA, etc.)
Perform qualification and validation activities according to site master plan
Generate project documentation and provide training to affected personnel
Assist with project management activities, as required
Use engineering expertise to assist in the execution of capital and expense projects for at the Coventry site.
Provide technical support for other Coventry functional groups, including;
Support during production activities to solve issues and help ensure safe and compliant execution of process procedures. On-call support will be required during new process start-ups.
Generate and own change controls, quality events, CAPA, etc. within the Coventry quality system to support on-going production.
Participate in team safety meetings and complete engineering related action items.
Support administration of engineering document repository (AutoCAD Vault).
Education and Experience:
Senior Process Engineer requires BS in Chemical Engineering with 7+ year of experience
.
Experience in manufacturing, engineering or project management work associated with pharmaceutical ingredients, specialty or fine chemicals.
Batch manufacturing experience with a wide variety of unit operations and related equipment.
cGMP manufacturing experience.
Experience in both the project engineering and process engineering.
Familiarity with cGMP's and FDA regulations.
Familiarity with OSHA Process Safety Management Standard and other relevant codes and regulations.
About Pharmaron - Who Are We?
Pharmaron is a premier R&D service provider for the life sciences industry.
Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products.
With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
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