Engr 1 Quality
Engr 1 Quality
Posted on :
23-11-2024
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1 Vacancy
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Job Description
Description:
Bill rate $41$47 depends on experience
100% onsite 5 days a week
Job Summary Validation QE II and SR QE(Validation) :
As directed by the Quality Engineering Leader the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies. Successful performance requires close work with quality management operations suppliers and/or BD associates to assure compliance with all BD quality policies procedures and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products. Preferred core experience in Quality Assurance Quality Control Validation (IQOQPQ) and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices ISO FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity using policies and procedures for guidance.
Job Responsibilities: (Primary Duties Roles and/or Authorities)
1. Experience performing equipment and process validation studies such as writing and/or reviewing protocol report data analysis and deviations for new existing and site relocation activities.
2. Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance Calibration and Out Of Tolerance activity support to the site and equipment owners.
3. Author and execute installation operational and performance qualifications for analytical and manufacturing equipment.
4. Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.
5. Review and update FMEA or Risk documents as needed for validation activity for the site
6. Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but not limited to execution of QA inspection to support dual operations review and approval of documents such as batch records to support finished product release.
Education and Experience:
BS Biological Sciences Chemistry Biotech engineering Bioengineering or related field
Minimum of 35 years of experience for QE II and 57 years for Sr. QE in Medical Device Biotech or Pharma Industry.
Knowledge and Skills:
1. Strong verbal and written communication skills; ability to write technical documents. Knowledge of
quality system methodologies
2. Statistical Analysis basic knowledge e.g Minitab or Excel
3. Strong knowledge of Process Validation and equipment validation
4. Strong understanding and knowledge on ISO 9001 ISO 14971 and/or ISO 13485 (Design Control Supplier Management and Risk Management)
5. Hands on experience using Six Sigma methodology
6. SAP knowledge
7. Equipment management system such as BMRAM knowledge preferred
8. The ability to work in teams and independently with minimal supervision to obtain results as required.
9. Must be selfmotivated/directed organized detail oriented and have ability to multitask projects.
Physical Demands: (if applicable)
1. General physical requirements: ability to work in controlled environmental
2. Ability to work with laboratory grade equipment such as refrigerators freezers centrifuges etc during validation work.
Work Environment: (if applicable)
1. Onsite model
2. Ability to be present in manufacturing area as needed
100% onsite 5 days a week
Job Summary Validation QE II and SR QE(Validation) :
As directed by the Quality Engineering Leader the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies. Successful performance requires close work with quality management operations suppliers and/or BD associates to assure compliance with all BD quality policies procedures and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products. Preferred core experience in Quality Assurance Quality Control Validation (IQOQPQ) and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices ISO FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity using policies and procedures for guidance.
Job Responsibilities: (Primary Duties Roles and/or Authorities)
1. Experience performing equipment and process validation studies such as writing and/or reviewing protocol report data analysis and deviations for new existing and site relocation activities.
2. Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance Calibration and Out Of Tolerance activity support to the site and equipment owners.
3. Author and execute installation operational and performance qualifications for analytical and manufacturing equipment.
4. Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.
5. Review and update FMEA or Risk documents as needed for validation activity for the site
6. Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but not limited to execution of QA inspection to support dual operations review and approval of documents such as batch records to support finished product release.
Education and Experience:
BS Biological Sciences Chemistry Biotech engineering Bioengineering or related field
Minimum of 35 years of experience for QE II and 57 years for Sr. QE in Medical Device Biotech or Pharma Industry.
Knowledge and Skills:
1. Strong verbal and written communication skills; ability to write technical documents. Knowledge of
quality system methodologies
2. Statistical Analysis basic knowledge e.g Minitab or Excel
3. Strong knowledge of Process Validation and equipment validation
4. Strong understanding and knowledge on ISO 9001 ISO 14971 and/or ISO 13485 (Design Control Supplier Management and Risk Management)
5. Hands on experience using Six Sigma methodology
6. SAP knowledge
7. Equipment management system such as BMRAM knowledge preferred
8. The ability to work in teams and independently with minimal supervision to obtain results as required.
9. Must be selfmotivated/directed organized detail oriented and have ability to multitask projects.
Physical Demands: (if applicable)
1. General physical requirements: ability to work in controlled environmental
2. Ability to work with laboratory grade equipment such as refrigerators freezers centrifuges etc during validation work.
Work Environment: (if applicable)
1. Onsite model
2. Ability to be present in manufacturing area as needed
Additional Details
- Exempt/NonExempt Status : NonExempt
- Industry Title : Quality Engr
- Job Group : 2
- Project Name : (No Value)
- Contract to hire position : No
- Shift : N/A
- Screening Requirements : N/A
Employment Type
Full Time
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