System Validation Engineer

2 days ago

Belgaum, Karnataka, India beBeeComputerSystemValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
System Validation Engineer Job Description\

We are seeking a highly skilled System Validation Engineer to join our team. The successful candidate will be responsible for ensuring that all computer systems meet the required validation standards.

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Key Responsibilities:

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  • \
  • Develop and implement system validation plans and procedures.\
  • Conduct risk assessments and identify potential system vulnerabilities.\
  • Perform testing and evaluation of system functionality.\
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.\
  • Document and maintain accurate records of system validation activities.\
  • Identify and recommend process improvements to enhance system validation efficiency.\
  • Stay up-to-date with industry regulations and standards, such as FDA and GxP guidelines.\
  • Communicate effectively with stakeholders, including project managers, engineers, and quality assurance personnel.\
  • Manage multiple projects simultaneously and prioritize tasks to meet deadlines.\
  • Work collaboratively in a fast-paced environment and adapt to changing priorities.\
  • Ensure that all system validation activities are performed in accordance with established policies and procedures.\
  • Participate in continuous improvement initiatives to enhance system validation processes.\
  • Provide input and recommendations on system validation strategies and best practices.\

Requirements:

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  • \
  • Bachelor's degree in Computer Science, Engineering, or related field.\
  • 5+ years of experience in system validation, preferably in a regulated industry (Medical Device/Pharma/Life Sciences).\
  • Strong knowledge of GxP regulations, including 21 CFR Part 820, 21 CFR Part 11, and ISO 9001.\
  • Hands-on experience with Electronic Document Management systems (EDMS) and test management tools.\
  • Excellent communication and interpersonal skills, with ability to work effectively in a team environment.\
  • Ability to analyze complex problems and develop effective solutions.\
  • Strong problem-solving and analytical skills, with ability to think critically and creatively.\
  • Experience with project management tools and methodologies, such as Agile or Waterfall.\
  • Willingness to learn and adapt to new technologies and processes.\
  • Ability to work in a fast-paced environment with multiple priorities and deadlines.\
  • Professional certification in system validation or related field is an asset.\

What We Offer:

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  • \
  • A competitive salary and benefits package.\
  • Opportunities for professional growth and development.\
  • A collaborative and dynamic work environment.\
  • The chance to work on challenging projects with a talented team.\
  • A comprehensive training program to support your career goals.\
  • A focus on work-life balance and employee well-being.\

How to Apply:

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If you are a motivated and detail-oriented System Validation Engineer looking for a new challenge, please submit your resume and cover letter to [insert contact information].

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We thank all applicants for their interest; however, only those selected for an interview will be contacted.

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