The Senior Process Engineer is responsible for the fulfillment of technical aspects of development and manufacturing of GMP development and production orders. Provides leadership to the company’s engineering efforts including process engineering development, and project execution in compliance with U.S. FDA Regulation 21 CFR Part 210, 211, and Part 820, where applicable.
Essential Duties & Responsibilities
- Investigate materials, process, tooling and equipment in order to best meet customer needs.
- Support quoting activities through communication of the scope of work required to meet customer objectives.
- Leads projects from product planning and administration through all development, testing, and product launch.
- Maintains a safe and clean extrusion operation.
- Writes detailed protocols for development trials.
- Supervise all extrusion development trials. Accountable for execution of all development orders in Delivery Science.
- Writes master batch production records for GMP campaigns.
- Mentor operators and associates to improve their technical competencies and knowledge of extrusion.
- Works closely with customers developing and understanding their requirements, time frame, and funding limitations.
- Assists in developing project plans specifying goals, strategy, scheduling, identification of risks, contingency plans, and allocation of available resources.
- Assists in planning and managing project development efforts including customer interaction, specifications, and design input documentation, product design requirements, manufacturing process development, risk analysis, design control, and process validations.
- Helps develop intellectual property.
- Develops new processes within a Class 10,000 clean room environment.
- Evaluates new equipment for use in Foster’s manufacturing operations.
- Follows validation and test plans, and procedures including all necessary documentation in compliance with U.S. FDA Regulation 21CFR Part 210, 211, and 820 as well as ISO 9001:2000. Keeps current with FDA Regulations, procedures, and policies.
- Supervises development and production runs requiring GMP manufacturing protocols.
- Assists in the installation of new equipment into Foster’s manufacturing operations. Develops, writes and executes IQ / OQ / PQ documentation on GMP manufacturing equipment.
- Supervises the execution of batch production records for cGMP trials. Where required, signs off on batch productions records.
- Accurately document equipment, tooling, materials and process requirements to manufacture products reliably.
- Calculates required product components and prepares bill of materials (BOMs) for products run in manufacturing.
- Troubleshoots processing issues on existing manufacturing processes.
- Assists manufacturing and QA in solving product problems that are related to either material of construction, product use environment, or the process of manufacturing. Provides technical support to manufacturing, sales, and QA concerning materials and processes.
- Provides guidance, advice and support to engineers and technicians in areas of: project leadership, technical consultation, and documentation, quality, and GMP procedures.
- Supports the quality functions by signing off on certificate of analysis/certificate of compliance reports when necessary.
- Performs other duties as directed or assigned.
Position is responsible for supervising 2 or more engineering technicians and/or machine operators.
· Knowledge of polymer processing, polymer materials, U.S. FDA Regulation 21CFR Part 210, 211, and 820 as well as ISO 9001:2000 Expertise in compounding of polymers. Works well in a team based work environment.
Education and/or Experience
· B.S in Engineering or Science (Plastics Engineering/Chemical Engineering/Biomedical Engineering/Materials Science) and a minimum of 4 years work experience in a related field; or M.S. in Engineering or Science with a minimum of 2 years work experience in a related field; or Ph.D. in Engineering or Science with a minimum of 1 years work experience in a related field Process engineering, manufacturing engineering, operations or project management experience required. Supervisory experience preferred. Interacting with customers is an ongoing responsibility in this position. Knowledge of medical device and/or pharmaceutical GMP is a plus. Experience with extrusion validations for the medical industry. Excellent communication skills with customers, fellow technical staff, and management.
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 regularly required to walk, talk, and hear. The employee is frequently required to stand for extended periods of time and to use hands to finger, handle and feel. The employee is occasionally required to sit; reach with hands and arms; climb and balance; and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include color vision.
The work environment characteristics 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 occasionally exposed to moving mechanical parts, fumes or airborne particles, and risk of electrical shock. The noise level in the work environment is usually loud. Hearing protection to be used at employee’s discretion.