[얀센백신] Technical Operations Engineer

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.


1. 포지션: Technical Operations Engineer
2. 계열사: 얀센백신 (Janssen Vaccines)
3. 근무지: 인천 송도


[Responsibilities]
1) Contribute to LCM / New Product Introduction for the Site
- Manage / execute the validation program related to LCM / NPI such as process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
- Issue / review validation plan, protocols and reports
- Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
- Be the site TO representative in LCM/NPI project teams as process / validation SME
- Overall coordination of LCM projects on site, under responsibility of global TO organization
- Change control Management
2) Technology & product technical life cycle management
- Manage / execute the annual site Validation Master Plan(s) in the area of process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
- Issue / review validation plans, protocols and reports
- Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
- Review / approve annual product reviews (APR)
- Own / lead or participate in the CPV (continued process verification) program by issuing plans, protocols and reports and oversee the execution.
- Lead complex investigations on the site by providing technical expertise (process, cleaning, aseptic, ...)
- Provides process / technology input to SOP’s, Master Batch Records and change controls
- Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
- Perform process development as part of process improvement (scale up, equipment transfer, performance improvement, packaging development,…)
3) Innovation & Standardization
- Identify / lead / contribute to process improvement projects, including new technology introduction (eg PAT)
- Contribute to Standardization initiatives for Technical Operations
4) Inspection Readiness and Execution
- Technical support in partnership with Quality on any regulatory audits and inspections
- Being the Spokesperson in Audits internal and external
5) Technical Owner
- The TO engineer can also take the role of Drug Product Technical Owner


[Requirements]
1) Specific knowledge
- Strong expertise on pharmaceutical manufacturing processes and equipment (Especially Aseptic Process related)
- Strong knowledge in the area of validation
- Project management (FPX or other) – team member of project lead depending on the role in the project
- Process excellence (6sigma), lean concepts and tools
- Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
- Statistical Skills
2) Personal and interpersonal skills / Leadership skills
- Ability to lead cross functional team – for those engineers / scientist leading projects in the site
- Ability to interact at different levels of the organization
- Ability to create a result oriented (project) team – for those engineers / scientist leading projects in the site
- Costumer and business focus
3) Good Manufacturing Practices (GxP)
- Adhere to applicable cGxP’s and procedures (role model)
- Report incidents and deviations
- Propose solution to improve compliance with cGMP’s
4) Safety, Health and Environment Performance
- Adhere to applicable EH&S and procedures (role model)
- Correct use of the available personal and collective protection materials
- Reporting of (near) accidents, incidents, deviations
- Cooperate on and suggest solutions to improve EH&S
- Actively promote EH&S, support campaigns/programs such as “Safe behavior’
- Act when violation of EH&S rules is observed and stimulate appropriate behavior


[JD 확인 및 지원 방법] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1700196821W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”


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[이메일 문의]
recruitment-jnj@ITS.JNJ.COM