Manufacturing Engineer

Tcs is hiring !!! Role: Manufacturing Engineer Ex: 6-8 years Loc: Kolkata, Bhubaneswar, Bangalore, Pune, Chennai

Responsibilities 6+ years’ relevant experience in manufacturing (preferably in medical device/Pharma) with strong knowledge in various manufacturing process. Experience in creating manufacturing process plans, process verification & validation, and equipment qualification (IQ/OQ/PQ) protocols & reports. Experience in creating the process risk management documentation such as process FMEAs. Experience in product variants and setting up the Bill of Material and routers. Experience in working with cross functional team such as packaging, labeling etc. Exposure to EU MDR and FDA requirements is preferred. Experience with chemical products such as liquid and powder. Proficient with MS Office applications such as MS Word, PowerPoint, Excel. Candidate should possess strong communication and inter-personal skills. Candidate must be able to perform assigned responsibilities independently with minimal guidance. Candidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines.

Must have Prior experience in Medical Devices Domain. Knowledge about IQ/OQ/PQ(Performance Qualification) and Validation Activities. PLM Change Management Process.

Good to have. Knowhow of Bill of Material, and routers set-up. Knowledge of Process FMEAs, Manufacturing control plan Equipment & Process Qualification (IQ/OQ/PQ) Degree in Manufacturing/Mechanical/Production engineering/equivalent. Create/update manufacturing process plans, work instructions, manufacturing process specification, Validation documents etc. Perform Gap assessment between the legacy process validation and current standard. Coordinate with team for the gap remediation.