Job Opportunity: Technical Process Manager
A key position in our organization requires a Technical Process Manager to oversee the development, optimization, and validation of pharmaceutical manufacturing processes. This role involves ensuring compliance with regulatory standards, driving continuous improvement initiatives, and supporting the implementation of new products.
This technical leader will collaborate with cross-functional teams to enhance efficiency, scale-up processes, perform NPIs, and troubleshoot manufacturing challenges.
Key Responsibilities:
* Process Development and Optimization: Oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
* Risk Management: Initiate and track the execution of process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
* Investigations and Resolutions: Drive resolution for investigations into deviations, non-conformances, and root cause analyses.
* Technical Scale-Up and Commercialization: Lead technical aspects of scale-up, tech transfer, and commercialization of new products.
* Validation and Compliance: Oversee the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
* Regulatory Compliance: Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
* Change Control and Support: Provide direction and expertise in the generation of change controls aligned with site procedures to support product/process changes.
* On-the-Floor Support: Manage on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
Requirements:
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
* 5 - 8 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
* Experience in sterile injectables or biologics manufacturing.