CQV Engineer / Validation Engineer
Description For CQV Engineer / Validation Engineer
Verista, a leading company in the life science industry, is seeking a CQV Engineer / Validation Engineer to join their team of 600 experts. This role offers an exciting opportunity to work with some of the world's most recognizable brands, solving critical business needs and contributing to innovative solutions in healthcare.
As a CQV Engineer, you'll be responsible for various aspects of software and medical device validation, including authoring and executing technical documentation, running test scripts, and maintaining detailed records. You'll play a crucial role in ensuring the quality and compliance of products that have the potential to improve lives.
The ideal candidate will have a Bachelor's degree in a STEM field (preferably Biomedical or Chemical Engineering) and 2-4 years of relevant industry experience. You should be familiar with Agile development practices and have some experience with scripting languages like Java, Python, or C. Strong problem-solving skills, attention to detail, and excellent communication abilities are essential for success in this role.
Verista offers a competitive salary range of $59,951 to $93,474, along with a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) plan with employer matching, and various other perks such as tuition reimbursement and paid parental leave.
This hybrid position is based in Indianapolis, Indiana, allowing for a balance between on-site collaboration and remote work flexibility. If you're passionate about making an impact in the life sciences industry and thrive in a team environment that values innovation and growth, this could be the perfect opportunity for you to advance your career with Verista.
Responsibilities For CQV Engineer / Validation Engineer
- Authoring, editing, and executing technical testing, commissioning, qualification and validation documentation for software/medical devices
- 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
- Developing, reviewing, and executing testing documentation
- Making recommendations for design or process modification based on test results
- General understanding of capital equipment implementation and process knowledge
- Understanding validation documents, URS, IQ, OQ, PQ
Requirements For CQV Engineer / Validation Engineer
- Must be willing to work onsite in Fishers, IN
- Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
- 2-4 years of relevant industry experience
- Knowledge of Agile development practices and/or software development lifecycles
- Experience with scripting languages such as Java, C, Python or similar is a plus
- Proficiency using PC and Microsoft Office tools
- Confident personality with strong ability to communicate effectively with peers in clear, concise terms
- Lead cross-functional projects as assigned
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- Good Documentation Practice training (may be completed at onboarding)
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
Benefits For CQV Engineer / Validation Engineer
- 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
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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