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Compliance & Validation Analyst

Job in Princeton - Mercer County - NJ New Jersey - USA
Company: UL
Full Time position
Listed on 2021-04-12
Job specializations:
  • Pharmaceutical
    Validation Manager Pharma
Job Description & How to Apply Below

At UL, we know why we come to work.

Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely!

As our global footprint continues to grow, we are looking for a Compliance & Validation Analyst. This position supports software compliance and validation efforts for UL's ComplianceWire SaaS in the Life Science industry.

What you’ll learn & achieve:

  • Responsible for developing, updating and documenting both new and existing IT Validation solutions.
  • Provide pre-sales support to address both how our platform complies with applicable validation regulations, as well as how our IT Validation solutions provide value and support for our clients.
  • Perform Computerized Systems Validation (CSV) project activities, including planning and developing validation strategies in conjunction with Quality and the Process Owners, creating all required GMP documentation as stated above, as well as executing the actual validations.
  • Coordinates and/or executes activities as per approved Protocol
  • Provide assessment, strategy, guidance and support to Quality and Process Owners with focus on both new and on-going validation and compliance activities.
  • Provides Subject Matter Expertise and assures implementation of best practices for IT System Validation to clients and our internal organization.
  • Provide guidance and support for our platform CSV framework based on FDA 21 CFR parts 11, 58, 211, 820, GAMP 5 and other regulatory requirements.
  • Review internal platform validation plans, test results, and summary reports for regulatory compliance.
  • Support client audits, provide risk assessment on product nonconformance, draft and/or review audit responses and assure deficiencies are adequately addressed.
  • Participate in assessments of partners or vendors of computerized systems, applications, and consulting services to assure that such services satisfy regulatory requirements and business objectives
  • Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.
  • Provide guidance and training to operational personnel on regulatory requirements for computerized system validation.
  • Responsible for learning from our clients their current and anticipated needs, trends in the industry, etc.
  • Develop trusting relationships with clients and internal UL personnel.
  • Manage multiple engagements simultaneously.
  • Continue to build Professional Service validation process, conduct webinars and lead meetings regarding key validation topics.
  • Possess strong leadership skills, and be interested in growth and development
  • What makes you a great fit:

  • Bachelor’s degree (B.A. /B.S.) or equivalent
  • Minimum of five (5) years of experience in the medical device, pharmaceutical, biotechnology, and/or biomedical industry.
  • Good knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211 and 820, Annex 11, GAMP 5 and related multinational industry standards and requirements.
  • Experience with application and hardware life cycle management, computer systems development.
  • Must be able to effective communicate and influence essential personnel from all business sectors.
  • Proficiency in computer based word processing, spreadsheet and presentation applications required.
  • Ability to travel up to 20% once COVID restrictions end
  • What you’ll experience working at UL:

  • Mission: For UL, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do.
  • People: Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL. We’re able to deliver the best because we employ the best.
  • Interesting work: Every day is different for us here as we eagerly anticipate the next innovation that our customers create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
  • Grow & Achieve: We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
  • Total Rewards: Total Rewards: All employees at UL are eligible for bonus compensation. UL offers a generous 401k matching structure of up to 5% of eligible pay. Additionally, we invest an additional 4% into your retirement saving fund after your first year of continuous employment. We provide Healthcare Reimbursement Accounts and Health Savings Accounts that UL contributes to twice per year! Depending on your role, you can work with your manager on flexible working arrangements. We also provide employees with paid time off including vacation, holiday, sick and volunteer time off.
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