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Senior Validation Engineer- Packaging

Company: Verista
Location: Buffalo Grove
Posted on: January 16, 2022

Job Description:

Who are we:
Looking for an exciting opportunity at a fast growing, employee-oriented company? Veristas 500+ experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. Whether its compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.
Veritas experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, were uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.
We deliver solutions that are right the first time.
Typical Responsibilities Include:

  • Manage the validation and documentation related to complex computer systems, multiple pieces of equipment/large upgrades/extensive product updates.
  • Responsible for reading the tray barcodes and saving that information as the distribution occurs. Applicator lines, running them through the sterilizer (multiple lanes) and distributed different Packaging lines. Taking tray data that is passed from line to line and stay with the parts.
  • Perform functions of validation engineer
  • Manage the systems and processes for change control and coordinate evaluation of proposed changes on regulatory filings, compliance, quality, outcomes and processes in pharmaceutical and medical device manufacturing and packaging operations.
  • Change management process owner for validation involving new or modified equipment, processes, procedures, products, facilities, and utilities. In this role, validation engineers design and perform validation around equipment and process improvements and changes, engineering studies, and manufacturing/packaging development
  • Review, validate and approve test results test summary reports
  • Determine and delegate tasks amongst a team to complete assignment.
  • Conduct impact analysis for validation and change management
  • Coordinate teams to complete validation testing activities
  • Manage complete document management and approval through clients process
  • Apply baseline C&Q knowledge, such as more complex validation efforts including CSV and drawing verification
  • Conducts regulatory impact analysis/assessment and, where warranted, makes recommendations to Lead.
    • A minimum of a Bachelors degree in an Engineering or Scientific degree and three to seven years industry experience.
      • 1-3+ years experience in GMP regulated environment (with Internship or co-op work experience considered as part of that experience)
      • Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
      • Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
      • Good Documentation Practice (GDP) in pharmaceutical environment
      • ASTM-E2500
      • ISO 14971 risk management for medical devices
      • ISPE Applied Risk Management for C&Q
      • ISPE Science and Risk Based Approach for the delivery of facilities, systems and equipment
      • ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools
        Because employees are the key to our success, Verista offers strong benefits and incentives including:
        • Health, Dental, and Vision Insurance
        • 401(k) Retirement Plan with a company match
        • Paid Time Off Pay
        • Tuition Reimbursement
        • 9 Company Paid Holidays
        • Paid Long Term & Short Term Disability Insurance
        • Training and Development
        • Paid Maternity Leave and Parental Leave
        • Travel Bonus
        • Employee Referral Program
        • Tuition Reimbursement
        • Marriage Leave
        • Bereavement
        • Verista is an Equal Opportunity Employerby Jobble

Keywords: Verista, Buffalo Grove , Senior Validation Engineer- Packaging, Engineering , Buffalo Grove, Illinois

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