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Project Engineer

Summit Biosciences Inc.

This is a Full-time position in Lexington, KY posted April 1, 2021.

nnResponsible for performing and leading process development, technical transfer and validation related activities in a cGMP environment. The scope of the position includes writing and revising SOPs, Production Batch Records (PBRs), Forms and validation documents, training Manufacturing Technicians to perform work in a safe, accurate and timely manner, assuring cGMP compliance, performing routine maintenance and troubleshooting of equipment and processes, independently performing validation activities, including writing protocols and reports and compiling data and attachments into comprehensive validation packages. Also responsible for assisting with the development of other engineering related documentation. May also perform routine preventive maintenance activities and manage validation and revalidation projects.nn nn nn nnProject Engineer is also responsible for leading projects to upgrade, optimize or troubleshoot systems, source and implement new equipment, reduce cycle times, increase efficiencies and serve as a technical expert on facility and equipment related issues. nn nn n nn nn Essential Duties: nn Lead activities to manufacture sterile nasal spray products in a cGMP environment.

Use Design of Experiment (DoE) to develop and optimize manufacturing processes for drug products.

Develop User Requirement Specifications (URS) for new capital equipment and conduct  Design Qualifications (DQ) for vendor proposals.

Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).

Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.

Write or revise calibration, maintenance, operating and safety procedures reflect current practices and maintain compliance.

Coordinate planned and emergency maintenance in all assigned areas.

Train technicians on safety, PBRs, SOPs, and cGMPs.

Maintain an inventory of supplies necessary for engineering activities.

Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).

Work on multiple projects simultaneously and coordinate work with various other departments. Plan, coordinate and track the progress of projects.

Write, execute and review validation protocols.

Execute calibration and maintenance activities and assure all related documentation is up to date and accurately reflects the current state.

Assist with the plant and manufacturing equipment acceptance, installation, startup, optimization and validation activities.

Assist with troubleshooting and repair of plant systems and equipment.

Manage projects such as; new equipment design and procurement, technology transfer, process optimization and scale-up, process and cleaning validations.

Participate in manufacturing campaigns as needed.

Other duties as assigned.

nn nn nn Qualifications: nn nn n nn BS in Engineering or related field or equivalent experience 3-7 years of experience in a cGMP manufacturing environment including hands-on engineering, tech transfer, manufacturing or validation experience Experience with Auto CAD or 3D CAD software Comfortable with statistical analysis using analysis of variance, process capability or other statistical methods when required Experience with sterilization processes and aseptic technique preferred Basic knowledge of Allen Bradley PLC hardware and RSLogix software Excellent technical writing and organizational skills Good mechanical aptitude Software requirements—Excel, Microsoft Project, Access and Minitab Good interpersonal skills and the ability to work well in a team environment Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment Excellent technical writing and organizational skills Self-starting and multitasking Extremely detail oriented Ability to work with cross functional teams and meet performance requirements Qualified to work with controlled substances  nn n nn nn   nn nn nn nn nn