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5941 - Senior CQV Engineer / Senior Validation Engineer Kalamazoo, MI
5941 - Senior CQV Engineer / Senior Validation Engineer Kalamazoo, MIVerista • Kalamazoo, MI, US
5941 - Senior CQV Engineer / Senior Validation Engineer Kalamazoo, MI

5941 - Senior CQV Engineer / Senior Validation Engineer Kalamazoo, MI

Verista • Kalamazoo, MI, US
19 hours ago
Job type
  • Full-time
Job description

Overview

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The company empowers growth and innovation within the scientific community and helps researchers, organizations, and companies solve healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives.

Company Culture, Values, and Responsibilities

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise
  • Authoring and performing execution of Verification Testing (Qualification) Protocols
  • Interacting with leadership and partnering with Engineering, Project Management, Automation, and other key stakeholders to establish priorities and define verification documentation and testing requirements for a portfolio of systems
  • Conducting and documenting impact and risk assessments with a full understanding of equipment / system / software operation and the ability to assess direct, indirect, and no impact systems and functions within complex processes
  • Communicating effectively with leadership and reporting daily / weekly project status
  • Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future audits
  • Designing and executing engineering studies for critical process parameter definition and verification prior to validation
  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment / systems / software and processes as part of the team
  • Adhering to project schedules for all assigned activities
  • Reviewing existing governing documents for revisions needed to facilitate new intended use of equipment
  • Making recommendations for design or process modification based on test results when executing test scripts

Requirements

  • Must be willing to work onsite in Kalamazoo, MI
  • Bachelor's Degree in Engineering or related discipline required
  • 7+ years experience in engineering and / or project management in Clean (Qualified) & Black (Non-Qualified) Utility Verifications plus Facility systems Qualifications
  • Experience with large scale small molecule and biologic manufacturing equipment including tanks, skids, WFI, autoclaves, filling lines, packaging equipment, etc.
  • Ability to mentor and guide less experienced team members
  • Experience and capability of effectively communicating requirements (written and oral) with rationale to different levels of the client's organization
  • Demonstrated experience in leading CQV activities specific to Process Equipment
  • Proficiency using PC and Microsoft Office tools
  • Ability to work as part of a team
  • Strong problem-solving and critical thinking skills
  • Strong attention to detail
  • For US geography, the salary range for this position is shown below. The actual salary depends on a variety of factors such as professional background, training, experience, location, business needs, market demand, and competitive market practice.

    National (US) Range

    $70,491 - $118,062 USD

    Benefits and Why Verista

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
  • Equal Opportunity and Privacy

    Verista is an equal opportunity employer.

    Verista collects and processes personal data in accordance with applicable data protection laws. For more information, please visit Verista.com.

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    Senior Validation Engineer • Kalamazoo, MI, US

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