[Janssen Vaccines] Sr. Project Engineer

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: Senior Project Engineer

2. 계열사: 얀센백신 (Janssen Vaccines)

3. 근무지: 인천 연수구

4. 근무 형태: Regular

[Job summary]

Established and productive individual contributor in the scientific/technology field. Implements strategic direction and key knowledge and expertise, for Project Engineering initiatives of strategic importance leading to the company's end-to-end supply chain customer-specific deliverable requirements. Develops and progresses significantly complex Project Engineering schematics, engaging cross-functional teams to ensure optimal supply chain engineering solutions.

Specifically:

Provide leadership and direct for process, engineering, commissioning and qualification of manufacturing facilities, systems, and equipment; and providing engineering and technical support for complex production and processing equipment. Partners with internal and external stakeholders including manufacturing, quality and venders.

• Supervision for Commissioning & Qualification site
• Drive engineering standards at site implementation
• Project execution and management for site projects (strategic, base/compliance)
• Coordinate with Technical Operations to ensure alignment with technology standards and engineering specifications for manufacturing technology
• Technical support for engineering issues

[Key responsibilities]

Advises top leadership of ongoing Project Engineering Supply Chain plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.

Identifies any Project Engineering non-conformance and subsequent corrective and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions. Completes capital and expense forecasts for assigned engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements. Analyzes process validations on Project Engineering processes for subsequent operational integration and supply chain implementation. Examines outputs of Project Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements. Identifies and communicates, in a timely manner, any Project Engineering issues or concerns to the next management level. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Lead execution of engineering projects and initiatives at site (strategic, base/compliance)

• Ensure attainment of project and program schedule, budget, and procedure by developing and monitoring the budget and approval process.
• Monitor the status of the program and project, provide technical interpretation and expertise, and ensure adherence to policies, procedures, government regulations, and customer specifications.
• Keep management informed on project and program status by creating, maintaining, and presenting written reports on project and program status, tests, costs, issues, and performance against established targets regularly.
• Ensures the documentation of project and program activities and deliverables.
• Ensure project compliance with EHS&S policies and procedures.

Provide technical leadership of cross-functional teams on many different projects/process improvements resolve inter-functional issues and support execution of EHS&S policies and procedures.

• Engineering SMEs to drive adoption and support projects for standard design platforms; train engineers on standards; work with E&PS to maintain and develop standard design platforms.
• Coordinate with Technical Operations to ensure alignment on technical standards and project execution for technical transfer projects/NPI.
• Maintain professional and technical knowledge by attending educational seminars and trade shows, reviewing professional publications, and analyzing new trends.
• Ensures proper system integration by overseeing the development of the systems integration and systems assurance test plans and procedures, and reviews test results.
• Develop and drive engineering standards throughout the platform and ensure the application of standards at the site.
• Engineering SMEs to support project delivery process, C&Q, and FPX standards to drive deployment. Work with E&PS to provide training, maintain, and update standards.
• Research business and technical issues to establish what is being done and where improvements are possible.

Execute activities & documentation related to all GMP requirement.

• Initiation of Quality Issue, Investigation, Root Cause Problem Solving, CAPA set up, make/revision of SOPs & WIs, technical document, qualification and etc as originator and reviewer.

Support audit and inspection for Engineering topics

[Qualifications:]

• A degree in Engineering/Science.
• Preferred Area of study: Engineering, related area of study
• Proven track record in Project Engineering/Management knowledge in the pharmaceutical industry, including design construction, commissioning, and qualification.
• Minimum 5+years of professional experience
• Advanced GMP/GXP knowledge
• Strong technical skills in pharmaceutical equipment and facilities engineering.
• Robust knowledge of Quality & Compliance/Regulatory requirements
• Strong communication and interpersonal skills
• Innovative mindset, Willingness to put team’s goal before one’s goal