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Position Summary
The Process Engineer in Technical Services is accountable for driving results in a fast-paced environment by providing technical support for Drug Product Development of products filled into vials and syringes. Projects range from Phase I clinical supplies to commercial supplies. This role will be responsible for ensuring clients have the best technical and engineering solutions for their products as it relates to the manufacturing process. The Process Engineer in this position will provide technical assistance including but not limited to the following: transfer of new process and technologies into the company, authoring appropriate documentation to support process transfer, sourcing of equipment and components, designing new disposable process flows, troubleshooting current validated processes, contribute to process deviations, and conduct investigations. The role is expected to support client projects by technical transfer of projects into GMP manufacturing, assuring regulatory compliance, and ensures standard operating procedures are understood and followed. This role must have working knowledge with tech transfer, scale-up, scale-down, equipment qualifications, process development, process improvements, process validations, and clinical manufacturing. In addition, this role must have working knowledge of QbD and risk assessments. These functions will be executed in accordance with FDA and EU current Good Manufacturing Practices and federal regulations. The person in this role will also train and mentors others in the organization. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Essential Functions
Education and Experience
Alcami Non-Negotiables
Alcami Core Leadership Competencies
Functional Competencies
Decision Making and Supervision Required
Travel Requirements
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk or hear; use hands to finger, handle or feel. The employee is occasionally required climb or balance and stoop, kneel, crouch, or crawl; reach with arms and hands. The employee must regularly lift and/or move up to 25 pounds, and some of the time move up to 50 pounds. While performing the duties of this job, the employee frequently works near moving mechanical parts, occasionally is exposed too fumes or airborne particles; risks of electrical shock or vibrations.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Full Time
Investment Management
$85k-98k (estimate)
07/21/2022
12/24/2022
alcaminow.com
WILMINGTON, NC
1,000 - 3,000
1979
Private
STEPHAN KUTZER
$200M - $500M
Alcami is a North Carolina-based CDMO that provides analytical development, formulation, packaging and testing services for the pharmaceutical sector.
The following is the career advancement route for Process Engineer positions, which can be used as a reference in future career path planning. As a Process Engineer, it can be promoted into senior positions as a Chemical Process Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Process Engineer. You can explore the career advancement for a Process Engineer below and select your interested title to get hiring information.