Manufacturing Engineer Job at Bangalore Urban, Karnataka, India 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 & s.
• 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.