Manufacturing Engineer

2 months ago

Bangalore Urban, India Tata Consultancy Services Full time

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.

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