Manufacturing Engineer
2 months ago
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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