The Process Improvement Engineer - Investigator is the technical support professional in the Manufacturing organization that has the delegated responsibility of directly ensuring the quality work outputs and the compliance of work practices. Incumbents will accomplish this by working directly with all support groups in the planning and execution of operations activities rather than inspecting for defects after the work has been completed. The Process Improvement Engineer - Investigator will employ working knowledge of regulations, quality management, and process improvement principles in the conduct of his/her responsibilities. Further, he/she will collect, evaluate and interpret performance indicator data to identify sub standard performance and/or performance improvement opportunities. The Process Improvement Engineer - Investigator will work with all support groups to implement the necessary change.
The Process Improvement Engineer - Investigator will have the responsibility of working across functional lines to facilitate project teams in the implementation of quality or compliance improvement. He/she will lead/coordinate the investigation activities related to product deviations and author the reports related to these deviations. He/she will initiate Corrective and Preventive Action plans related to deviations and ensure the on time implementation. He/she is viewed as a subject matter expert on operational quality, work process design and control, and technical problem solving. As such he/she is highly visible and demonstrates highly effective oral and written communication skills. His/her ability to create a team approach to the management of quality and compliance is a critical success factor for the incumbent.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Applies an advanced knowledge of regulatory compliance requirements and operations quality principles in the operations to which he/she is assigned.
- Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors.
- Leads cross functional teams engaged in quality/compliance improvement activities.
- Facilitates the increased quality/compliance knowledge of assigned area.
- Serves as primary resource and technical subject matter expert in areas of troubleshooting, problem solving, process/method improvement, and the assuring the quality and compliance of these activities
- Directs complex technical and/or organizational problem solving activities using proven tools such as statistical analysis, screening experiments, Design of Experiments (DOE) etc
- Reviews, Revises and Writes Standard Operating Procedures, study design plans, qualification and/or validation protocols, investigational test plans, investigation reports, change control requests and other operational documentation
- Identifies negative trends in quality/compliance and ensures correction of root causes of deficiencies.
- Discusses projects with various members of the Manufacturing and Engineering personnel to review functions of machines and equipment.
- Makes sound judgments and decisions and provides proper advice on issues of regulatory compliance and/or work product quality nature
- Drives the implementation and enhancement of policies and procedures consistent with regulatory policies, customer expectations, and fundamental principles of quality
- Assure the identification and implementation of advanced quality and compliance management principles and techniques resulting in positive changes in operations
- Operates with minimal level of direct supervision
- Assumes leadership role in managing projects, develops technical and organizational recommendations with significant impact, and uses influence to drive ongoing improvement of quality and compliance
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must use effective time and project management skills in carrying out responsibilities.
Demonstrates ability to independently handle multiple projects simultaneously.
Articulates and supports Thermo Fisher Scientific strategy, direction, and decisions, assuring their proper execution within the Manufacturing organization
Demonstrates role model behavior consistent with Thermo Fisher Scientific Values
EDUCATION AND EXPERIENCE:
- Four year BA or BS Degree in scientific or engineering discipline
- Minimum of 2 years related experience in a pharmaceutical environment required. Quality background preferred.
- Must be capable of improving systems and processes and investigating related issues. Must have investigation process experience.
- Must have strong technical writing and report writing experience.
- Must be able to lead without authority
- DOE experience preferred.
CERTIFICATES, LICENSES, REGISTRATIONS
Prior LEAN and or Six Sigma experience preferred. Six sigma green or black belt certification preferred.