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6212- Laboratory Validation Engineer / Validation Engineer 2

West Chester, OH

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

Laboratory Validation Engineer Responsibilities:

  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
  • Running test scripts and documenting results.
  • Adherence with project schedule for all assigned activities
  • Maintaining clear, detailed records qualification and validation
  • Documenting impact and risk assessments as part of a team
  • Completing user interface testing, software verification
  • Making recommendations for design or process modification based on test results when executing test scripts
  • Hands on experience with lab techniques and general lab analytical operations
  • Understanding of baselined lab standards and system suitability verification
  • Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows
  • Direct experience with system design and/or configuration activities
  • Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
  • Independent verification of testing against specifications
  • Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis
  • Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release.

Requirements:

  • 2-5 years of role relevant experience
  • Experience with Veeva Vault preferred 
  • Demonstrated ability to generate CQV/CSV deliverables independently within GMP regulated laboratory environments
  • Ability to work independently and as part of a team, with the ability to transition between the two
  • Capacity to make independent sound decisions and independently manage priorities
  • Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
  • Proven attention to detail and organization in project work Bachelor’s Degree or equivalent required
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
  • Strong problem-solving and critical thinking skills
  • Excellent organizational and time management skills
  • Strong attention to detail
  • Experience with and tolerance for high levels of challenge and change
  • Ability to work a minimum of 3 days per week onsite in West Chester, OH in a hybrid capacity

 

 

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

$65,000 - $90,000 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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