Highlights
Bachelor's Degree and 0 years of relevant experience, or Associate's Degree and 2 years of relevant experience, or High School Diploma or Equivalent and 4 years of relevant experience. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses.
Numbers & Facts
| Location | Warsaw |
| Industry | Computer/IT Services |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Manufacturing Engineer I
Work Location: Warsaw, IN, 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Principal Duties and Responsibilities:
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Manufacturing Engineer I
Work Location: Warsaw, IN, 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Principal Duties and Responsibilities:
- Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipment
- Support a wide variety of Equipment qualifications including CNC machines
- Guide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validation
- Create change requests in windchill to support equipment moves
- Execute to project plans and schedules for work activities.
- Communicate (written and verbal) with appropriate personnel from other departments.
- This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
- Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
- Experience writing and executing validation protocols and reports, including IQ/OQ/PQ documentation
- Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
- Good problem-solving skills through the use of quality and statistical tools.
- Ability to effectively work within a cross-functional team to complete critical project tasks.
- Demonstrates good written and verbal communication skills.
- Strong technical writing and documentation skills
- Ability to independently develop and execute on project plans.
- Demonstrated ability to take initiative and provide recommendations on process, procedure and training.
- B.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing.
- Bachelor's Degree and 0 years of relevant experience, or Associate's Degree and 2 years of relevant experience, or High School Diploma or Equivalent and 4 years of relevant experience
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.