Process Validation Engineer/ Asso. Process Validation Engineer

Role & responsibilities

Associate Engineer would work with global IZiel Teams & Customer to successfully complete all

deliverables within time and budget.

• Participate in daily project meetings with IZiel India Team & communicate priorities, customer requirements, ensure deliverables are completely understood and set clear expectations.

• Co-ordinate with IZiel India Team to ensure deliverables are met as per customer with an

Onshore Offshore Model.

• Conduct Quality Check on deliverables from India Team prior to submitting to the customer.

• Engineer would prepare Design & Development Documents to align with the regulatory strategy.

• Engineer would prepare validation plan & report, requirements traceability matrix, equipment

specifications, IQ, OQ, PQ, URS, Initial Risk Assessment, Test Method Validation, FAT, SAT etc.

• Must have hands on experience on PPAP, FMEA, Cp/Cpk, SPC, Supplier Quality, 5 Core Quality Tools, Six Sigma Trained.

• Utilize statistics to analyze data, characterize process and perform process validation activities with support from the global team.

• Engineer would receive on the job training in Document Preparation, Requirements.

• Management, Risk Management along with introduction to Six Sigma, Lean Manufacturing etc

Preferred candidate profile

• Degree in Mechanical Engineering /Automobile Engineering
• 1- 5 years of work experience in the Medical Device Industry, Automobile Industry, Defence Aerospace Industry, Manufacturing Industry, Heavy Machinery Industry.
• Willingness to travel, if required
• Strong Communication Skills along with Presentation & Coordination Skills (Written & Oral)
• Preparing Technical documentation.
• Team Player with ability to complete projects within timeline.
• Attention to detail with task prioritization capabilities.
• Team Player with Strong Behavioral Skills
• Great attendance, a positive attitude, and the ability to work under pressure.
• Knowledge of MS-Office tools like Word / Outlook / Excel
• Experience in client co-ordination

• Candidate should have excellent communication skills
• Candidate should be able to relocate to Pune if out of Pune
• No Work from Home or Hybrid
• Freshers can also apply