Come Join Our Growing Team!
We are looking for a Senior Process Engineer to join our dynamic and growing team in Coventry, RI!
Position Summary:
The Senior Process Engineer in the Pharmaron Coventry 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 manner.
Principal Accountabilities:
The Sr. Process Engineer must be able to apply technical leadership skills across a broad range of engineering challenges in support of small-molecule API manufacturing. Critical to the success of this position is adherence to cGMP and OSHA Process Safety Management (PSM) regulations while implementing robust production processes and designing efficient, multi-purpose chemical processing equipment.
The responsibilities of the Process Engineer include:
- Provide advanced engineering support for the technical transfer of new chemical processes from concept through product delivery, including calculation of mass and energy balances, equipment selection, unit operation modeling, and generation of manufacturing batch records, protocol, and associated GMP production documents.
- Design and install new chemical process equipment and/or modifications to existing equipment supporting new process requirements or new site manufacturing capabilities.
- Interface with internal project management and external clients during project meetings to effectively communicate project status, maintain adherence to schedules, and solve technical challenges.
- Manage process safety risks with team-based accountability for PSM implementation using existing Coventry procedures for evaluation of thermal, explosion, and electrostatic hazards, vent sizing, process hazard analysis, etc.
- Provide engineering support during new manufacturing start-up to effectively solve production issues, ensuring safe and compliant execution of process procedures. On-call support will be required during new process start-ups.
- Generate and own completion of change controls, quality events, CAPAs, and GMP documentation within the Coventry electronic quality and document management systems to support on-going production.
- Provide technical leadership and guidance to less experienced engineering staff in the Manufacturing Technology group during the execution of engineering projects.
- Lead equipment qualification and process/cleaning validation activities according to site validation master plan and internal procedures.
- Maintain accurate engineering files through the creation, revision and approval of electronic drawings, requirements, specifications, operating manuals, etc.
- Interface with technical resources based at other Pharmaron manufacturing sites to establish best practices and/or bring new manufacturing technologies to the Coventry facility.
- Provide owner direction to contract resources towards completion of engineering and/or construction projects at the Coventry site.
Education and Experience:
Senior Process Engineer requires Bachelor of Science Degree in Chemical Engineering or closely related field with 7+ years of experience.
- Experience in manufacturing and/or process engineering associated with pharmaceutical ingredients, specialty, or fine chemicals.
- Batch chemical manufacturing experience with a wide variety of unit operations and chemical process equipment.
- Experience executing engineering design projects and/or manufacturing operations under cGMP.
- Familiarity with FDA regulations, OSHA PSM standard, and other relevant codes and regulations.
- Excellent verbal and written communication skills to facilitate interaction with clients, regulators, external vendors, etc.
- Experience in project engineering preferred, but not required.
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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