MSAT Process Specialist
MSAT Process Specialist
The Perfect Candidate possesses a degree in Chemical, Biochemical Engineering, or a related field, coupled with a minimum of three years of relevant industrial experience. This experience should be in platform-specific areas such as technical process development, process engineering, or manufacturing operations (eg, DS Bio, DP SM). Essential Experience and Knowledge: Demonstrated experience (3+ years) in process engineering, technical process development, process validation, or technology transfer. Strong familiarity with pharmaceutical quality systems and industry-wide guidelines relevant to platform-specific process development and manufacturing.
Tasks & Responsibilities:
* Support Product Technical Leads and Product Stewards to ensure process industrialization (eg facility t and manufacturability, PPQ support as needed, etc…), coordinate and execute process gap assessments, integrating identified risks into the risk log and developing mitigation strategies.
* Drive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategies
* Execute validated state support activities, such as WCB shipment, sample coordination for additional studies, and non-routine sampling planning, and respond to evolving conditions to ensure compliance (eg VICs, RCAs, etc.)
* Ensure the implementation of network initiatives aligned and prioritized with manufacturing site plans
* Incorporate/execute portfolio-wide impacting aspects (eg direct material changes; Health Authority requirements;
* Perform defined technical Product Life Cycle activities to ensure product robustness from development through divestment
* Execute process-related mitigation of complaints and deployment of CAPAs across multiple sites or products
* Drive technical sustainability improvements for product, process, and technology, including digital advancements
* Closely collaborates with global and site functions (sometimes external) and leadership, including other gMSAT and PTT teams, particularly close partnership with E2E Product Technical Leads and DS or DP Technical Leads
* Serve as a digital enabler translating business needs to digital strategy and digital product development teams
Must Haves:
* BS or MS degree in Chemical, Biochemical Engineering, or related discipline with 3+ years of relevant industrial experience in platform specific technical process development, process engineering or manufacturing operations (eg DS Bio, DP SM, etc.), PhD can be of advantage
* Technical Expertise: 3- years demonstrated experience in process engineering, technical process development, process validation or technology transfer, with pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing, with regulatory submission and health authority requirements, and with platform specific technology, processes and equipment
Reference No.: 924882
Role: MSAT Process Specialist
Industry: Pharmaceuticals
Workplace: Basel
Workload: 80 - 100%
Start: ASAP
Duration: 6+ months
If you are interested in this position, please send us your complete dossier. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
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About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees. jid089a2aaja jit0624ja jiy26ja