Scientific Experienced Engineer – External Supply Integration (ESI) (Contractor)
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1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Non-StandardJob Sub Function:
Non-EmployeeJob Category:
Non-StandardAll Job Posting Locations:
Shanghai ChinaJob Description:
Position
Scientific Experienced Engineer External Supply Integration (ESI)
Temporary role based in Shanghai China Primary responsibility: management of our main supplier in China
About the Department
Join the Global Pharmaceutical Product Development and Supply (PPDS) organization within Therapeutics Development and Supply (TDS) at Johnson & Johnson. PPDS drives development of innovative pharmaceutical dosage forms across our centers in the US Asia and Europe. This temporary ESI role sits in the Pharmaceutical Supply & Engineering Sciences (PSES) organization and will be based in Shanghai working closely with the global PSES and DP development teams (Beerse/Antwerp and other sites).
Role summary
We are hiring an External Supply Integration (ESI) Scientific Experienced Engineer to act as the PSES lead for clinical drug product manufacturing at our main supplier in China. The roles primary focus is the day-to-day management coordination and technical oversight of clinical manufacturing activities at that supplier ensuring rightfirsttime introductions robust tech transfers and ongoing supplier performance aligned with global GMP and project timelines.
Key responsibilities
- Serve as the single PSES point of contact and the primary technical lead for our main supplier in China managing the supplier relationship and acting as the interface between the supplier and internal DP development QA regulatory and supply chain teams.
Lead clinical manufacturing introductions and follow-up at the main supplier: drive readiness execute and oversee tech transfers validate processes for oral solids liquids and parenterals and ensure rightfirsttime outcomes.
Coordinate manufacturing plant readiness supply execution and operational oversight at the supplier site (including site visits and onsite escalation).
Manage supplier performance and risks: proactively identify criticalpath issues lead corrective actions and implement preventative process improvements.
Prepare review and approve manufacturing instructions batch records and specifications in collaboration with internal stakeholders and the supplier.
Support scale-up and transfer activities from pilot/internal sites to the supplier and onward to commercial manufacturing when applicable.
Work crossfunctionally with development quality regulatory and supply chain to ensure compliance with GMP regulatory expectations and company standards.
Facilitate communications and alignment across global teams to ensure smooth clinical supply operations and timely deliveries.
Participate in supplier qualification activities and support supplier audits together with QA when required.
Qualifications
MSc or PhD in chemistry pharmaceutical sciences (bio)chemical or mechanical engineering or related discipline. Minimum of 2 years experience in GMP-regulated pharmaceutical development/engineering (clinical manufacturing/CDMO interactions preferred).
Practical experience with oral solid dosage forms liquids and/or parenteral products; familiarity with conventional and some innovative technologies (e.g. spray drying extrusion continuous manufacturing) and basic knowledge of process analytical technologies is desirable.
Proven experience managing an external manufacturing partner (CDMO/supplier) in China or across the Asian region demonstrated ability to manage onsite activities and supplier performance.
Strong knowledge of GMP and regulated environments; able to translate regulatory expectations into supplier actions and documents.
Excellent project coordination risk management and problemsolving skills with a bias for action.
Strong collaboration and influencing skills; experience working in international crossfunctional teams.
Fluent in English (written and spoken). Proficiency in Mandarin is strongly preferred. Dutch is a helpful additional skill.
Willingness to travel up to 20% (including supplier site visits).
Ability to work independently under tight timelines while maintaining quality standards.
Required Skills:
Preferred Skills:
Required Experience:
Senior IC
Key Skills
- APIs
- Jenkins
- REST
- Python
- SOAP
- Systems Engineering
- Service-Oriented Architecture
- Java
- XML
- JSON
- Scripting
- Sftp
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
