SENIOR PROCESS VALIDATION ENGINEER

Job Location: Pune

IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device

manufacturing. We partner with customers to support them for all aspects of medical device Product

Development Life Cycle.

Employees are the key to success in our organization. We value our engineers and their skills in furthering

the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional

customer service are the key enablers of our success.

POSITION DESCRIPTION:

Provide Engineering Leadership & Project Management Support at IZiel for product development lifecycle

of medical devices from Gap Assessment, Design Control, Engineering Documentation, Process Validation

(IQ, OQ, PQ, TMV, TMD) to Acquisition Integration Projects. Must successfully manage the customer

requirements, oversee all aspects of projects, set deadlines, assign responsibilities, monitor and

summarize the progress of project, manage the deliverables and lead IZiel Team in US. Project

Management responsibilities include the coordination and completion of projects on time within budget

and within scope and thereafter present reports to upper management regarding project status.

POSITION RESPONSIBILITIES:

• Project Lead would work with IZiel Team & Customer to successfully complete all deliverables

within time and budget.

• Co-ordinate with IZiel customer to understand their requirements, prioritize the tasks & ensure

deliverables are met as per customer needs.

• Develop long-term relationship with existing customers & ensure customer satisfaction.

• Participate in daily project meetings, drive discussions towards completion for emphasis on

following quality systems and rigorous documentation to complete deliverables.

• Work with IZiel India Team to execute the project with an Onshore – Offshore Model.

• Regular participation in meetings with IZiel India Team & communicate priorities, customer

requirements, ensure deliverables are completely understood and set clear expectations.

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

• Provide expertise in Design Control, Process Validation, Risk Management, QMS, DHF

Remediation & Documentation to IZiel Team.

• Project Lead would develop as well as guide the team to develop Design Control documents to

align with the regulatory strategy.

• Project Lead would develop Validation Plan & Report, review relevant documents like test plan,

requirement traceability matrix, equipment specifications, IQ OQ PQ, Initial Risk Assessment, Test

Method Validation, FAT, SAT etc.

• Utilize statistics to analyze data, characterize process and perform process validation activities

with support from global team.

• Create or Upgrade QMS Procedures, Plans in accordance to 21 CFR 820, ISO 13485 etc.

• Understand Customer Requirements, Specifications and accordingly make recommendations/

improvements for existing concepts, processes and methodologies.

• Resolve queries, customer concerns & drive the project to completion

• Develop & present project plan, key issues/ risks to the customers.

• Understand opportunities for work outside of IZiel scope and present the customer with plan,

methodologies to complete the same by IZiel Team.

• Impart knowhow of Six Sigma, Lean Manufacturing, Document Preparation, Requirements

Management, Risk Management via training, on the job teaching etc

• Must have a good understanding of various guidelines, standards, compliance including but not

restricted to cGMP Regulations, 21 CFR, ISO 13485 & ISO 14971.

• Perform audit compliances, analyze gaps, shortcomings as per FDA/ISO regulations

DESIRED/PREFERRED QUALIFICATIONS:

• 10+ years experience in the Medical Device Industry with strong execution abilities.

• Team Player with ability to complete projects within timeline and budget

• Strong & Clear Communication, Presentation & Coordination Skills (Written & Oral)

• Ability to coordinate with customer, manage requirements and successfully complete

deliverables.

• Attention to detail with task prioritization capabilities (Tactical, Operational & Strategic)

• Working understanding of FDA, GMP and ISO 13485.

• Experience with basic statistics and/or reliability methodologies and technical writing

• Willingness to travel

• Bachelor – Engineering Degree or any Advanced Science Degree