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**Job Function: **
Supply Chain Engineering
**Job Sub Function: **
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Schaffhausen, Switzerland
Job Description:
Summary:
This role supports life cycle management (LCM) and process optimization for large‑molecule parenteral products within MSAT global department. Execution of process development studies and supportive tech‑transfer tasks, analyzes process data, aids PAT/digital tool rollout and support Annex1 process changes. Ensures GMP/ICH compliance, and collaborates with cross‑functional and external partners.
Key Responsibilities
- Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM) and 2nd TT.
- 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 access data driven changes for 2nd TT or LCM activities
- Plan and execute process development studies in the lab on product to support lifecycle decisions for unit operation (freeze/thaw, mixing, filtration, filling)
- Lead filter validation activities with external partners
- Support new technology , PAT and digital tool implementation to commercial processes
- Ensure GMP/ICH compliance; document
- 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 information technology and building up the LCM department
- Support process modeling and the statistical analysis of data.
- Contributes 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 related; 5+ years in MSAT/LCM/Tech Transfer in pharma/biotech
- Strong hands‑on experience executing lab studies and process validations with external vendors/CMOs
- Skills on data‑evaluation using tools (e.g., JMP, Minitab, Excel).
- GXP experience in Pharma production and Laboratory
- Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management.
- Proficient in English; German language skills are optional.
- Creative, flexible and open-minded
- Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management.
Location:
This role requires a minimum of 3 days a week onsite presence at the JNJ Schaffhausen site. More days onsite per week may be required, depending on Lab study execution. Flexibility is expected to ensure timely study execution in the Labs.
**Required Skills: **
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