Johnson & Johnson companies are equal opportunity employers.
SR. QA VALIDATION ENGINEER-2239131118
Description
Janssen Supply Chain, a member of Johnson & Johnson's Family of Companies is currently recruiting for a Senior QA Validation Engineer located in Vacaville, CA.
Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior QA Validation Engineer will conduct quality and compliance review and approval of documentation related to validation (FAT, SAT, IQ, OQ, PQ, and FQs) for both day-to-day activities and special projects. It will approve equipment and facility change control documents and provide guidance for User Requirement Specifications, Validation Master Plans and Risk Assessments (FMEAs). The position represents QA on Engineering Project / Capital Project teams including new and retrofitted production equipment and facilities upgrades including Purified Water and AHUs.
The Senior QA Validation Engineer will lead Quality projects related to i.e.; production, new product launches, equipment and facility and departmental process improvements. The position will perform quality reviews and approvals of documentation related to production, equipment and facility. As the Subject Matter Expert, provide compliance guidance for process, equipment and facility qualifications (IQ, OQ, PQ, FQ). This responsibility requires participation on the Engineering Project teams during planning, in to ensure that equipment and system design, procurement and testing is conducted in accordance with all regulatory requirements.
The Senior QA Validation Engineer works closely with Engineering Validation, Packaging Engineering and Process Engineering to develop and maintain complaint processes. It will assess gaps in current systems, partner to develop and implement process improvement and set and communicate QA/regulatory requirements. This is completed through daily interactions, training, SOP updates, system updates etc. It will represent QA on Engineering Project/Capital Projects teams, identify, resolve and correct production related NCR’s and investigate QA technical process or equipment issues that arise from Departures, Technical Complaints, audits etc. The Senior QA Validation Engineer provides technical support for QAS, CAPA. The position is located in Vacaville, CA and requires up to 5% domestic and international travel.
Qualifications
It is required the Senior QA Validation Engineer have a minimum of a High School Diploma or equivalent. A BA / BS Degree in an Engineering or Science related field is preferred. A minimum of five years of engineering experience required. It is required to possess a minimum of three years of experience in an FDA / cGMP regulated industry required. Pharmaceutical industry experience preferred. It is required to have technical writing capabilities and strong verbal communication skills. A minimum of two years of equipment, process and cleaning qualifications experience is required. It is required to have a minimum of three years of validation knowledge and experience. Analytical and technical problem solving skills required. Knowledge of 21CFR parts 210 and parts 211 are required. The ability to lead the OATS team and the ability to implement and lead department initiatives preferred. The position is located in Vacaville, CA and requires up to 5% domestic and international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-California-Vacaville
Organization: Alza Corporation (6002)
Job: Quality (Eng)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
SR. QA VALIDATION ENGINEER-2239131118
Description
Janssen Supply Chain, a member of Johnson & Johnson's Family of Companies is currently recruiting for a Senior QA Validation Engineer located in Vacaville, CA.
Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior QA Validation Engineer will conduct quality and compliance review and approval of documentation related to validation (FAT, SAT, IQ, OQ, PQ, and FQs) for both day-to-day activities and special projects. It will approve equipment and facility change control documents and provide guidance for User Requirement Specifications, Validation Master Plans and Risk Assessments (FMEAs). The position represents QA on Engineering Project / Capital Project teams including new and retrofitted production equipment and facilities upgrades including Purified Water and AHUs.
The Senior QA Validation Engineer will lead Quality projects related to i.e.; production, new product launches, equipment and facility and departmental process improvements. The position will perform quality reviews and approvals of documentation related to production, equipment and facility. As the Subject Matter Expert, provide compliance guidance for process, equipment and facility qualifications (IQ, OQ, PQ, FQ). This responsibility requires participation on the Engineering Project teams during planning, in to ensure that equipment and system design, procurement and testing is conducted in accordance with all regulatory requirements.
The Senior QA Validation Engineer works closely with Engineering Validation, Packaging Engineering and Process Engineering to develop and maintain complaint processes. It will assess gaps in current systems, partner to develop and implement process improvement and set and communicate QA/regulatory requirements. This is completed through daily interactions, training, SOP updates, system updates etc. It will represent QA on Engineering Project/Capital Projects teams, identify, resolve and correct production related NCR’s and investigate QA technical process or equipment issues that arise from Departures, Technical Complaints, audits etc. The Senior QA Validation Engineer provides technical support for QAS, CAPA. The position is located in Vacaville, CA and requires up to 5% domestic and international travel.
Qualifications
It is required the Senior QA Validation Engineer have a minimum of a High School Diploma or equivalent. A BA / BS Degree in an Engineering or Science related field is preferred. A minimum of five years of engineering experience required. It is required to possess a minimum of three years of experience in an FDA / cGMP regulated industry required. Pharmaceutical industry experience preferred. It is required to have technical writing capabilities and strong verbal communication skills. A minimum of two years of equipment, process and cleaning qualifications experience is required. It is required to have a minimum of three years of validation knowledge and experience. Analytical and technical problem solving skills required. Knowledge of 21CFR parts 210 and parts 211 are required. The ability to lead the OATS team and the ability to implement and lead department initiatives preferred. The position is located in Vacaville, CA and requires up to 5% domestic and international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-California-Vacaville
Organization: Alza Corporation (6002)
Job: Quality (Eng)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.