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5757 - Senior CQV Engineer / Senior Validation Engineer

5757 - Senior CQV Engineer / Senior Validation Engineer

Verista, Inc.Kalamazoo, MI, US
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Job Description

Job Description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

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. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values :

  • 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

Overview : The qualified Senior Validation Engineer will support multiple workstreams including prep / form, fill / freeze dry, utilities, etc. While these are the key workstreams, the ability to shift priorities and prove experience across a range of equipment is highly desired. The ideal candidate should hold large scale aseptic Process Equipment C&V experience, needs to be independent with insightful understanding of core C&V requirements, and must have a proactive understanding of required actions / deliverables.

Senior Validation Engineer Responsibilities :

  • Operate according to SOPs developed for MAP Project Qualification strategy and general GEP / cGMP compliance
  • Provide or arrange for development of complete verification documentation in accordance with Quality Standards and cGMP requirements for assigned projects
  • Raise and Implement system change controls as required
  • Develop and implement changes required to resolve deviations / non conformances effectively
  • Participate in design review for new / modified utility systems
  • Participate in construction system mechanical completion walkdowns
  • Author and perform execution of Verification Testing (Qualification) Protocols (VTPs) in field
  • Assist with execution of temperature mapping of equipment
  • Assist with pre and post study calibration verifications
  • Effectively interact with leadership and partner with Engineering Verification, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define verification documentation and testing requirements for the portfolio of systems within the assigned area
  • Collaborate with matrix organization to optimize Equipment Verification / Validation / Change Control implementation

    • Requirements :

  • Education : Minimum of a Bachelor of Science (BS) Degree in Engineering or Related Discipline from a fully accredited institution
  • Experience : Minimum of 4 years of engineering and / or project management experience in Clean (Qualified) & Black (Non-Qualified) utility verifications plus facility systems qualifications
  • Communication Skills : Excellent oral and written communication skills, including presentations
  • Experienced in a pharmaceutical / FDA-regulated manufacturing environment
  • Working knowledge of cGMP and facility / equipment validation requirements
  • Ability to write clearly, concisely, and persuasively in a professional environment
  • Must be able to write and develop / revise strategy and lifecycle documents
  • Execution will not occur at start; however, experience in execution of equipment verification is necessary for future phases

    • Only qualified candidates local to Kalamazoo, MI will be considered.

    For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

  • Verista is an equal opportunity employer.

    • National (US) Range

    $70,491—$118,062 USD

    Benefits

    Why Choose 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.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

    • Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

    For more information about our company, please visit us at Verista.com

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    Validation Engineer • Kalamazoo, MI, US