Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Process Engineer in commercial operations is responsible for managing, developing and implementing process reviews and improvements to ensure equipment and facilities operate correctly and meet applicable GXP requirements. The reviews need to meet internal company standards and customer expectations.
Essential Duties and Responsibilities:
- Leads continuous improvement efforts and foster a work ethic of accountability.
- Informs management of issues identified during process evaluation and improvement activities.
- Recommends appropriate actions to address issues.
- Leads in the development of test plans to ensure risk mitigation and quality requirements are met. Serve as site representative / liaison on all Global Serialization matters. Ensure harmonization with Global standards/approaches.
- Provide expert subject matter support on Serialization Equipment related issues
- Serve as Site Administrator on all Serialization Software
- Perform job evaluations and assist in the selection, specification building, and onboarding of new equipment and clients.
- Performs impact analysis of changes to facilities and equipment.
- Identifies, facilitates, participates, and/or leads process improvements.
- Ensures qualification documentation deliverables meet internal and regulatory standards.
- Provides suggestions and improvements regarding work related processes and procedures.
- Performs risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes and materials.
- Serves as an expert in qualification of equipment and facilities.
- Assists in the writing and review of standard operating procedures (SOP).
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Mechanical Engineering – ability to install printers, inspection stations, control cabinets and other associated mechanical equipment
- Electrical Engineering – ability to wire printers, inspection stations, HMI controllers, PLCS terminals, etc.
- Drawings – Ability to verify supplier drawings and as-builts to confirm against design specifications.
- Must have strong analytical skills. Experience in Lean Manufacturing, Six Sigma, and PPI. Well versed in process improvement and industrial design applications.
- Requires demonstrated proficiency with the latest MS Office products, including Outlook, Word, Excel.
- Requires excellent analytical business skills with above average oral and written communications skills.
- Requires a Bachelors degree in a technical/life science discipline, or related field.
- Requires 3+ years of related work experience.
- Requires demonstrated experience with implementing successful TPS-based business systems including elements such as Value-stream mapping.
- Requires previous experience with Kaizen events on standard work, cell design, process and product 3P, Value-Analysis/Value Engineering, error-proofing, material flow, heijunka, and kanban.
- Requires demonstrated expertise in problem-solving utilizing a formal program/process
- Requires a broad knowledge of similar operations in a regulated industry.