Process Engineer

The candidate for this position will be responsible to execute and monitor the Process Engineering requirements of Formulation (Novel Drug Delivery Systems), developing, scaling up, technology transfer, optimizing, and validating robust formulation manufacturing processes for complex and novel drug delivery systems. The role acts as a technical bridge between Formulation R&D and commercial manufacturing, ensuring consistent product quality, regulatory compliance, and operational efficiency., including quality and compliance. The candidate should also be able to recommend improvements to the process through the tracking of metrics and reporting of data.

The candidate should definitely have strong technical abilities in order to succeed in this role. Responsibilities Provide technical support as necessary Establish process metrics and goals Develop and issue process designs Qualifications Bachelor's or Master's degree Chemical Engineering equivalent experience in Process development / Technology transfer activities / part of new product launch campaign - NDDS Formulations 05–10 years of experience in pharmaceutical formulation process development or manufacturing sciences. Hands-on experience with NDDS such as modified-release, nano-formulations, injectables, or lipid-based systems.

Technical Skills : Strong understanding of formulation science and process scale-up principles. Experience with GMP manufacturing environments. Knowledge of DoE, QbD, and risk management tools.

Familiarity with advanced processing equipment and PAT tools. Behavioral Competencies : Strong analytical and problem-solving skills. Excellent cross-functional communication and collaboration.

Detail-oriented documentation and compliance mindset. Ability to manage multiple projects in a fast-paced environment Roles & Responsibilities : Process Development and Optimization : Develop and optimize scalable formulation processes for NDDS products. Translate laboratory-scale processes into pilot and commercial-scale operations.

Identify and define Critical Process Parameters (CPPs) and process design space. Optimize unit operations such as granulation, coating, nano-emulsification, spray drying, lyophilization, and encapsulation. Troubleshoot process issues related to yield, variability, and product performance.

Scale-Up and Technology Transfer : Lead formulation scale-up from development to commercial manufacturing. Prepare and execute technology transfer (TT) protocols to internal or external manufacturing sites. Support equipment selection and scale equivalency assessments.

Provide on-site and remote support during exhibit, validation, and initial commercial batches. Process Characterization and QbD : Apply Quality by Design (QbD) principles to NDDS formulation processes. Identify Critical Quality Attributes (CQAs) and establish CPP–CQA relationships.

Design and execute Design of Experiments (DoE) for process understanding. Perform risk assessments using tools such as FMEA and Ishikawa. Validation and Commercial Support : Author and support execution of process validation (PPQ) and continued process verification activities.

Support cleaning validation for complex APIs and excipients. Investigate process deviations, OOS/OOT events, and implement CAPAs. Drive continuous improvement initiatives for process robustness and efficiency.

Regulatory and Documentation Support : Contribute to CMC sections (Module 3) of regulatory submissions. Prepare process descriptions, control strategies, and scale-up justifications. Support regulatory inspections and audits (US FDA, EMA, MHRA, CDSCO).

Author and review process flow diagrams, batch manufacturing records, and change controls.