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Process Validation Manager (m/f/d) Munich, Germany

Process Validation Manager (m/f/d) Description

Job #: 51584
EPAM is committed to providing our global team of 36,700+ EPAMers with inspiring careers from day one. EPAMers lead with passion and honesty and think creatively. Our people are the source of our success and we value collaboration, try to always understand our customers’ business, and strive for the highest standards of excellence. In today’s new market conditions, we continue to support operations for hundreds of clients around the world remotely, with the vast majority of our teams working from home. No matter where you are located, you’ll join a dedicated, diverse community that will help you discover your fullest potential.

DESCRIPTION



Join our team and become part of our success story as Process Validation Manager (m/f/d)!

You are curious, persistent, logical and clever – a true techie at heart. You enjoy living by the code of your craft and developing elegant solutions for complex problems. If this sounds like you, keep reading to learn more about this exciting role!

Come and join EPAM where Engineering is in our DNA.

Responsibilities

  • Analyzing the production process of consumables and devices for use in ophthalmology, including process-requirement specification and validation for each production stage (Internal and External)
  • Manage the Process Validation Master Plan during Equipment Qualification and Process
  • Validation for new and existing products and processes
  • Manage the Process during Equipment Re-Qualification and Process Re-Validation for new and existing Products and Processes
  • Validation of QMS software for production that affects product compliance
  • Coordination of the release into the final production process after equipment qualification, QMS software validation and process validation was successful completed
  • Push all project tasks independently by collecting required information for managing all production process relevant validation task and required technical documentation activities according to internal standards
  • Coordination planning and of equipment qualification and record
  • Release of qualified equipment into the production process
  • Maintain the list of all released validated processes and update if required
  • Planning, Initiation and Recording the data for regular monitoring for all validated production processes
  • Train SME for process validation and equipment qualification
  • Assessment and evaluation of the urgency of problems within the validated process environment
  • Highlighting top priorities to management

Requirements

  • At least 5 years of professional experience in the field of medical products, especially sterile disposable products
  • Solid experience and state—of-the-art knowledge of the Design Control Process for Medical Devices according to MDR and MDSAP requirements
  • Experience in product and process validation of sterile disposable
  • Expertise in the following standards is advantageous:
    • ISO 13485 / 21 CFR 820
    • ISO 11137: Sterilization of health care products
    • ISO 11607: Packaging for terminally sterilized medical devices
    • ISO 10993: Qualification of Biocompatibility
  • Very good English skills, both written and spoken

We offer

  • Competitive compensation depending on experience and skills
  • Regular performance assessments
  • Opportunities for personal and professional growth
  • Unlimited access to LinkedIn learning solutions
  • Friendly and enjoyable working team
  • Relocation package support
  • Regular corporate and social events
  • 30 days holiday per annum
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