Supply Chain Engineering – Process Engineering
This role supports life cycle management (LCM) and process optimization for large‑molecule parenteral products within the MSAT global department. It involves executing process development studies, analyzing data, supporting PAT and digital tool rollouts, and ensuring GMP/ICH compliance while collaborating with cross‑functional and external partners.
Key Responsibilities
* Prepare, review, and approve technical protocols, reports, and product impact assessments related to LCM and 2nd technical transfer.
* Apply and improve lab‑scale models to evaluate process parameters and ranges; translate findings to scale‑up and confirm or adjust critical/key parameters.
* Analyze process data and apply data‑driven changes for 2nd TT or LCM activities.
* Plan and execute process development studies in the lab to support lifecycle decisions for unit operations such as freeze/thaw, mixing, filtration, and filling.
* Lead filter validation activities with external partners.
* Support new technology, PAT, and digital tool implementation to commercial processes.
* Ensure GMP/ICH compliance and document all activities.
* Collaborate globally with cross‑functional teams and commercial supply chain to review process performance data in depth and drive process improvements.
* Enable MSAT digital capabilities and establish the LCM function by implementing tools, processes, and training to streamline scale‑up and support tech‑transfer and process changes.
Other Responsibilities
* Opportunity to develop process engineering skills and data analysis.
* Support the department’s information technology and help build the LCM department.
* Support process modeling and statistical analysis of data.
* Contribute to best practice initiatives aimed at streamlining process development processes to enhance efficiency and effectiveness.
Required Qualifications
* MSc/PhD in Pharmacy, Chemical Engineering, Biotechnology, or a related field.
* 5+ years of experience in MSAT/LCM/Tech Transfer within the pharmaceutical or biotechnology industry.
* Strong hands‑on experience executing lab studies and process validations with external vendors/CMOs.
* Expertise in data evaluation using tools such as JMP, Minitab, or Excel.
* GXP experience in pharmaceutical production and laboratory operations.
* Familiarity with GMP/ICH and systems such as LIMS, MES, and SAP; strong stakeholder management skills.
* Proficient in English; German language skills are optional.
* Creative, flexible, and open‑minded approach to problem solving.
Location
This role requires a minimum of 3 days a week onsite presence at the JNJ Schaffhausen site. Additional onsite days may be required depending on lab study execution. Flexibility is expected to ensure timely study execution in the labs.
Required Skills
* Agile Decision Making
* Coaching
* Corrective and Preventive Action (CAPA)
* Critical Thinking
* Emerging Technologies
* Issue Escalation
* Lean Supply Chain Management
* Problem Solving
* Process Control
* Process Engineering
* Product Costing
* Product Improvements
* Science, Technology, Engineering and Math (STEM) Application
* Situational Awareness
* Technical Research
* Technologically Savvy
* Validation Testing
* Vendor Selection
Preferred Skills
* Agile Decision Making
* Coaching
* Corrective and Preventive Action (CAPA)
* Critical Thinking
* Emerging Technologies
* Issue Escalation
* Lean Supply Chain Management
* Problem Solving
* Process Control
* Process Engineering
* Product Costing
* Product Improvements
* Science, Technology, Engineering and Math (STEM) Application
* Situational Awareness
* Technical Research
* Technologically Savvy
* Validation Testing
* Vendor Selection
#J-18808-Ljbffr