[Janssen Vaccines] Engineer in MSAT

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 athttps://www.jnj.com/.

At Johnson & Johnson, we all belong.

1. 포지션: Engineer in MSAT Validation team ( Manufacturing Science and Technology)

2. 계열사: 얀센백신 (Janssen Vaccines)

3. 근무지: 인천 연수구

4. 근무 형태: Regular

[Job summary]

This role is within the Manufacturing Science and Technology (MSAT) group at the Incheon manufacturing site that is responsible for validation and/or qualification of manufacturing equipment related to sterilization and mapping.

• Growth opportunities in the field of sterilization and mapping by engaging in validation and qualification activities.
• Experience in the validation process and GMP related to manufacturing equipment and knowledge building in technical and GMP documentation and practice

[Key responsibilities]

1. Coordinate and execute Validation and Qualification activities

• Manage and coordinate validation and qualification activities including sterilization and mapping.
• Perform technical assessment of related topics
• Collaborate with QA, engineering and Operations on validation/qualification and its related activities

2. Coordinate or support investigation, process improvement and standardization

• Lead or support failure investigations (escalation of quality or compliance events)
• Lead or support continuous improvement of validation and qualification activities
• Collaborate with global SMEs across the sites in deploying standards and global initiatives

3. Inspection Readiness and Execution

• Be the Spokesperson in Audits internal and external for related topics
• Prepare for the inspection in partnership with global MSAT, Quality and other functions for the related topics and/or areas

[Qualifications:]

• Over 2 years of experience in pharmaceutical manufacturing processes, products, or equipment
• Basic understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and validation (e.g., FDA, GMP, ICH, ASTM, ISPE, PDA etc.)
• Decent level of expertise in fundamental GMP, direct working experience in manufacturing or Quality is a plus
• Direct or indirect experience in Aseptic and/or sterilization is preferred
• Experience in process excellence (6sigma) or lean is preferred
• FPX (Project management, organizing, planning and coordination skills) is preferred
• A degree in Bio/Chemical or related
• Proficient in speaking and writing the country language and English language.

[JD 확인 및 지원 방법]

https://careers.jnj.com-> Requisition number “2406215561W” 검색 -> 해당 모집 공고 클릭 후, “Apply Now”

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www.careers.jnj.com

QUALIFICATIONS

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Summary

• Job Title[Janssen Vaccines] Engineer in MSAT
• FunctionSupply Chain Engineering
• Sub FunctionProcess Engineering
• CategoryEngineer, Process Engineering (ST4 – E24)
• LocationYeonsu-gu, Incheon, South Korea
• Date PostedOct 04 2024
• Requisition Number2406215561W