[Janssen Vaccines] MSAT - Staff Engineer - 2406196865W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ .

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

1. 포지션: MSAT – Staff Engineer

2. 계열사: 얀센백신 (Janssen Vaccines)

3. 근무지: 인천 송도

4. 근무 형태: Regular

[Summary]

This role is within the Manufacturing Science and Technology (MSAT) group at the Incheon manufacturing site that is responsible for Life Cycle Process Validation (LCPV), Process validation and improvements, process and material evaluations, and deployment of standard/new technologies.

• Lead a team of scientists and engineers across MSAT team Incheon site and collaborate with global SMEs across sites to excel site business units.

• Opportunities in the field of Aseptic or sterilization by experiencing hand-on GGMP validation activities and documentation.

• Growth opportunities in non-technical areas by engaging in scheduling meetings, CAPA/CC meetings as well as business driven meetings.

[Main responsibilities]

1. Lead Validation and Qualification activities

• Manage and coordinate validation and qualification activities including Aseptic process simulation/Air flow pattern test activities

• Perform technical assessment of sub-team related topics

• Collaborate with QA, engineering and Operations on validation/qualification and its related activities

2. Manage manufacturing data and trend analysis

• Support or lead initiatives for process robustness optimization and competitiveness.

• Analyze production data and provide operational expertise based upon intensive GMP knowledge of process in aseptic techniques and extensive process.

3. Lead investigation, process improvement and standardization

• Lead or support complex failure investigations (escalation of quality or compliance events)

• Lead continuous improvement of validation and qualification activities

• Contribute to standardization initiatives for Technical Operations.

• Collaborate with global SMEs across the sites in deploying standards and global initiatives

4. Lead Inspection Readiness and Execution

• Technical support in partnership with Quality on any regulatory audits and inspections with a focus on validation and qualification

• Being the Spokesperson in Audits internal and external

[Experience/Knowledge]

• Over 8 years of experience in pharmaceutical manufacturing processes or products or equipment

• Direct or indirect experience in Aseptic and/or sterilization

• Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and validation (e.g. FDA, GMP, ICH, ASTM, ISPE, PDA etc.)

• People management or Tech transfer experience is a plus

• Experience in process excellence (6sigma) or lean is a plus

• FPX (Project management, organizing, planning and coordination skills) is a plus

• Strong expertise in fundamental GMP, direct working experience in manufacturing or Quality is a plus

• Proficient in speaking and writing the country language and English language.

[JD 확인 및 지원 방법 ]

https://careers.jnj.com (https://careerhub.jnj.com) -> Requisition number “2406196865W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”

[ 제출 서류 ]

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[ 서류 마감일 ]

채용시 마감

[ 유의사항 ]

• 국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.

• 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.

• 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.

• 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.

www.careers.jnj.com

Qualifications

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Primary Location Asia Pacific-South Korea-Incheon-Yeonsu-gu

Organization Berna Biotech Korea Corporation (8856)

Job Function Process Engineering

Req ID: 2406196865W