Process Engineer Specialist - Injectable
- Dr. Reddys
- 5 - 10 years
- Hyderabad
- 5 years ago
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Job Description
Job Description :Delivery responsibility for the injectable and other suit of products by combining engineering and process understanding, working closely with the Development & Manufacturing Teams. Establishes and leverages effective access to repositories of information and intellectual capital within and outside the company that lend value to Product understanding, optimization and across scale execution. Process Engineering: Exhibit decent expertise in Injectable dosage form, in the areas of QbD and process engineering to understand the developed process at POC scale. Demonstrate knowledge of material characteristics and impact on stability, & manufacturability to design experiments for validation of assumptions for selection of prototype formulations. Abreast with modeling, engineering based scale up, advanced data analysis, PAT based control strategies. Process Optimization: Providing necessary technical inputs during interaction with R&D scientists for process robustness w.r.t. scalability, operability and cost effectiveness; Involving in process optimization with focus on right CPPs, CQAs and CMAs across scale. Interface with Development and Plant Execution teams, to facilitate translation of engineering principles to execution and leverage their expertise for robust manufacturing process across scales. Documentation: Preparation of PE Package ;Preparation of Safety Documents ; Preparation of gate meeting presentations; BPR Preparation and review; Review of Trial and validation documents(Trial protocol, Validation protocol, Trial report, Validation report) in-line with the project timelines; SBP technical evaluation for project suitability Execution of Batches: Ensuring facility preparedness at plant for batch execution against the proposed modifications; Batch monitoring in coordination with CFT teams; Ensuring successful execution of plant batches as per requirements; Trouble shooting of any process related issues at plant; Monitoring project related experiments at Vendor sites [FAT, SAT etc.]; Regulatory Support: Support and Guide the preparation of responses for complex/ major queries from regulatory authorities/customers related to process development and manufacturing. Key Personal Attributes: Ability to analyse data. Strong communication. Ability to lead projects independently. Ability and willingness to acquire new skills. Willing to travel and work at plant. Technical Required: Strong Chemical engineering principles Strong understanding of complex injectable products and QbD/QbC principles Experience with product Scale up and Technology transfer. Able to comprehend relevant literature and keep abreast with latest technologies in the field. Operating Network: Internal - FR&D Tech Leads, Experts, Delivery Managers, AR&D, Project Managers/PMO, RA, IPM, Sourcing, Production, MSAT, QA/QC, FTL, SHE. External - Equipment vendors, Equipment vendors, CROs/CMOs, Consultants External API manufacturers, Excipients and Packaging material suppliers. CRO, CMO, Development Partner s & Regulatory Authorities. Educational & Experience:
BE/B Tech/M Tech/ PhD Chemical Engineering from premier institutes with 5 to 10 Years of experience. Experience in sterile injectable dosage form, plant exposure, managing a team and Green/Black belt certification is desirable.
Job Classification
Industry: Medical, Healthcare, HospitalsFunctional Area: Architecture, Interior Design, Role Category: Architectural ServicesRole: Architectural ServicesEmployement Type: Full timeEducation
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Post Graduation Not RequiredDoctorate: Any Doctorate in Any Specialization, Doctorate Not Required, Ph.D in Any Specialization, M.Phil. in Dermatology, Other DoctorateContact Details:
Company: Dr. ReddysLocation(s): Hyderabad+ View Contact
Keyskills: CRO Data analysis Prototype Chemical engineering Manufacturing process Packaging Clinical trials Healthcare Black Belt Monitoring
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