Sr. Process Engineer I - Lexington, MA | Biospace
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Sr. Process Engineer I

WAVE Life Sciences

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Location:
Lexington, MA
Posted Date:
6/19/2017
Position Type:
Full time
Job Code:
01
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Manufacturing, Pharmaceutical,

Job Description

Working at the direction of the engineering leader, supports setting up a GMP compliant clinical manufacturing facility.  Assists with manufacturing engineering, process scale-up and problem solving with regards to equipment and systems.  Collaborates with and supports Facilities, Process Development, Quality, Supply Chain groups.


Responsibilities:
May include some or all of the following:
•   Setting up a GMP compliant manufacturing facility for Oligonucleotide production including equipment installation, start up and commissioning.
•   Lead the equipment qualification program and support process validation efforts.
•   Work with external partners and vendors for developing specifications for equipment, instruments, and materials of construction.
•   Lead preventive maintenance of production train as assigned.
•   Develop material balance and active process engineering based on materials flow.
•   Develop P&IDs to the process specifications.
•   Perform process scale up with input from Process Development and the Manufacturing teams.
•   Effectively collaborate with other team members, including engineers, chemists, quality specialists, and technicians for GMP plant operations.
•   Address manufacturing deviations and implement corrective actions based on sound scientific analysis.
•   Maintain a safety-first approach to manufacturing and support the in-house EHS program.

Requirements

Education / Experience:
•   Master’s in Chemical Engineering with 5-7 years of experience in GMP/clean room manufacturing environment.
•   Equipment Qualification and Validation IQ/OQ/PQ experience in GMP/clean room environment.
Skills / Pre-requisites:
•   Working knowledge of methods and procedures used in the manufacture and quality control of APIs required.
•   Working experience with API associated equipment and downstream purification equipment (Chromatography, TFF).
•   Working experience with CAD or similar P&ID developing tools.
•   Must be highly motivated with good organizational and analytical/technical problem solving skills
•   Must be a self-starter with capability of working under minimal supervision and work well in a team based environment
•   Have effective written and oral communication skills
•   Computer skills in Microsoft Office suite including Project and Visio
•   Design of Experiments (DOE)