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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
Learn more about EPAM in Germany

Equal Employment Opportunity

EPAM Systems, Inc. is an equal opportunity employer.  We recognize the value of diversity and inclusion in creating success for our customers, business partners, shareholders, employees and communities. We are committed to recruiting, hiring, developing and promoting employees without discrimination. As a global employer, this commitment includes complying with all laws in the countries in which we operate. Nevertheless, we believe equal employment practices should not be limited to what the law requires. Equal opportunity and inclusion are essential to motivate, empower and recognize the best in everyone.

At EPAM, employment actions are based on individual qualifications, without regard to race, color, religion, creed, gender, pregnancy status, sexual orientation, gender identity, gender expression, marital or familial status, national origin, ancestry, genetics, age, disability status, veteran status, citizenship status when otherwise legally able to work, or any other characteristic protected by law.

Pay Transparency Non-Discrimination Provision

EPAM will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Affirmative Action Obligations as a U.S. Government Federal Contractor

As a U.S. federal government contractor, EPAM is committed to meet its affirmative action obligations to make good faith efforts to expand the recruiting pool of women, minorities, individuals with disabilities, and protected veterans through outreach, targeted recruitment, training opportunities and other activities. We affirm this commitment annually in EPAM’s Affirmative Action Plans. The full text of our Affirmative Action Plan for Persons with a Disability and Protected Veterans is available for inspection in the People Operations Department during normal business hours. Email the People Operations Department to schedule an appointment.

Accessibility for Applicants with Disabilities

EPAM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you require an accommodation at any stage of the employment application process, please send an email to the People Operations Department including your name, a detailed description of your requested accommodation, and the best method to contact you. If you have already reviewed a job posting or submitted an application for a job, please include the requisition number. We will assist you and make a determination on your accommodation request on a case-by-case basis.

EEO is the Law. Applicants to and employees of EPAM Systems Inc., are protected under Federal law from discrimination.

EPAM Systems, Inc. participates in eVerify.

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