Process Development Engineer Biotech Jobs (NOW HIRING)

Location: Elkton MD Relocation: Yes Type of products: CO2 Absorbents Overview: The Process Engineer is responsible for supporting current processes and the development and implementation of new processes and will be reporting to the Head of Engineering. The engineering team is lean, flexible and nimble, and so the Process Engineer should expect also to collaborate with personnel in product development, engineering, quality and technology. We are rapidly growing our medical anesthesia system CO2 absorbent products. Our absorbents are on 80% of the free world submarines and all new US miliary SCUBA rebreathers are integrating the technology. We need a process engineer to support growth in these businesses by qualifying new processes and equipment, as well as supporting ongoing process needs. Qualifications: • Citizen or permanent resident (green card) of the United States • Bachelor of Science degree or higher in Mechanical, Chemical, Materials or Manufacturing Eng • Minimum 3-5 years' experience supporting industrial processes • Solid understanding of process engineering and development • Experienced in process flow charts and visualization • Experience installing or modifying and qualifying production or QC testing equipment • Solid statistical knowledge and use of associated software, Excel, StatE, Minitap • MS Project or equivalent software experience used in the planning and execution of projects • Strong technical understanding in equipment and processes • Integrity • Completes tasks in a timely and thorough manner • Multi-tasks and prioritizes effectively • Takes initiative and ownership for results • Documents results, Organized and neat, and learns quickly • Runs effective meetings; prepares, defines objectives, documents path forward • Works well with and respects people at all levels in the organization Desired Qualifications: • Experience with ISO 13485 documentation requirements • Experience with injection molding equipment installation, manufacturing, and process engineering • Experience with polymer processing, including extrusion • Experience with FMEA's • Experience with chemical plant processes • Design of experiment experience, using software such as Stat-Ease • Experience with Lean and Six-Sigma techniques • Experience operating under ISO 9001:2018 Quality Management System • Experience operating under ISO 13485 Quality Management System • Experience of ISO 13485 documentation requirements Essential Functions: • Process methodology and equipment • Design and execute experiments in support of process/ development and continuous improvement • Support and/or Lead capital expansion projects • Support plant expansion by running and validating new equipment • Increase throughput and decrease waste for targeted processes • Liaise with contractors, suppliers, and other outside parties to support process needs • Track and document process metrics • De-bug process upsets • Provide and maintain process work instructions • Apply sound basic knowledge of safety, environmental, and energy-related best practices during the execution of projects • As necessary, required to wear designated personal protective equipment to include, but not limited to, ANSI-approved safety eyewear, respirators, hardhats, gloves, hearing protection, full face shield, aprons, and footwear to prevent exposures to hazardous materials, noise, dust and/or airborne particles • Perform other related duties assigned by the Head of Engineering • Sit at computer workstations 80% of the time and stand/walk 20% of the time • Tolerate noise levels from office, production, and lab equipment • Hear telephonic equipment and comfortably communicate by telephone and in person. • See details at close range (within a few feet of the observer) as required for business software and operating office and production machines • Lift up to 40 lbs. • Bend, squat or crouch, crawl, kneel, stoop, stretch, and stand while performing tasks to meet job requirements Note: Benefits include: • Group Medical Insurance • Group Dental Insurance • LTD, STD, and Life Insurance • 401K Retirement Savings Plan with company match • Access to voluntary insurance programs via Colonial Life • 80 Hours of Paid Time Off • Eight holidays