Validation Engineer
- Employer
- DivIHN Integration, Inc
- Location
- Saint Paul
- Salary
- 45.00 - 48.50 USD Hourly
View more
- Industry
- Engineering and Architecture
- Role
- Engineer
- Job Type
- Long-Term
- Hours
- Full Time
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at
Divya at
Title: Validation Engineer
Duration: 8 Months
Location: St. Paul, MN
Description:
JOB DUTIES: - Must perform process validation, process capability, and process control studies for assigned areas
- Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
- Must participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks. Partner with other support groups and manufacturing teams to complete work. - Must ensure computer systems and applications are in compliance with regulatory quality standards through validations activities. - Responsible for creating the documents required for the development and validation of computerized systems.
- Must be able to understand, test, and debug applicable software while following the software life cycle procedures.
- Responsible for ensuring FDA regulations are met for system upgrades/replacements.
- Responsible for ensuring the quality of facility systems (validation):
Writing and executing protocols and test cases for validations.
Coordinating testing and documentation of projects.
Documenting/executing changes to applications.
Assisting/leading training for systems.
Develop test requirements, and prepare and document test data for complex system testing.
Provide support to resolve technical issues with systems under validation - Ability to function effectively as a member of a team.
- Ability to communicate effectively in written and verbal form.
- Must perform all other duties and responsibilities as determined by supervision/management.
- This position will be implementing software driven system while working with engineering and IT. The basic understanding of software systems and how to appropriately test is mandatory.
QUALIFICATIONS: - BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 1 -3 years of experience.
- Knowledge of applications such as Wonderware, Allen-Bradley PLC, Access, Microsoft Project preferred.
- Experience with databases such as Oracle is helpful.
- Experience with installation, administration, and maintenance of servers is helpful
- Familiarity with programming languages, such as SQL, etc
- Leadership skills.
- Logical thought process.
- Ability to work with diversified cross functional team across different plant locations.
- Self-motivated and work well without direct supervision.
- Ability to quickly learn and understand applications.
- Quality Assurance or Pharmaceutical industry experience desired.
- Candidates must meet visual acuity requirements as documented in the Client Cleveland Human Resources Procedure CL-01-01-037
Job Type: Contract
Pay: $45.00 - $48.50 per hour
Benefits:
Dental insurance
Health insurance
Life insurance
Referral program
Schedule:
Monday to Friday
Application Question(s):
BS in Engineering
How many years of experience in creating the documents required for the development and validation of computerized systems?
Familiarity with applications such as Wonderware, Allen-Bradley PLC, Access and with databases such as Oracle and with programming languages, such as SQL, etc?
Work Location: One location
Rashi at
Divya at
Title: Validation Engineer
Duration: 8 Months
Location: St. Paul, MN
Description:
JOB DUTIES: - Must perform process validation, process capability, and process control studies for assigned areas
- Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
- Must participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks. Partner with other support groups and manufacturing teams to complete work. - Must ensure computer systems and applications are in compliance with regulatory quality standards through validations activities. - Responsible for creating the documents required for the development and validation of computerized systems.
- Must be able to understand, test, and debug applicable software while following the software life cycle procedures.
- Responsible for ensuring FDA regulations are met for system upgrades/replacements.
- Responsible for ensuring the quality of facility systems (validation):
Writing and executing protocols and test cases for validations.
Coordinating testing and documentation of projects.
Documenting/executing changes to applications.
Assisting/leading training for systems.
Develop test requirements, and prepare and document test data for complex system testing.
Provide support to resolve technical issues with systems under validation - Ability to function effectively as a member of a team.
- Ability to communicate effectively in written and verbal form.
- Must perform all other duties and responsibilities as determined by supervision/management.
- This position will be implementing software driven system while working with engineering and IT. The basic understanding of software systems and how to appropriately test is mandatory.
QUALIFICATIONS: - BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 1 -3 years of experience.
- Knowledge of applications such as Wonderware, Allen-Bradley PLC, Access, Microsoft Project preferred.
- Experience with databases such as Oracle is helpful.
- Experience with installation, administration, and maintenance of servers is helpful
- Familiarity with programming languages, such as SQL, etc
- Leadership skills.
- Logical thought process.
- Ability to work with diversified cross functional team across different plant locations.
- Self-motivated and work well without direct supervision.
- Ability to quickly learn and understand applications.
- Quality Assurance or Pharmaceutical industry experience desired.
- Candidates must meet visual acuity requirements as documented in the Client Cleveland Human Resources Procedure CL-01-01-037
Job Type: Contract
Pay: $45.00 - $48.50 per hour
Benefits:
Dental insurance
Health insurance
Life insurance
Referral program
Schedule:
Monday to Friday
Application Question(s):
BS in Engineering
How many years of experience in creating the documents required for the development and validation of computerized systems?
Familiarity with applications such as Wonderware, Allen-Bradley PLC, Access and with databases such as Oracle and with programming languages, such as SQL, etc?
Work Location: One location
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