Verista

6406- Senior CQV Engineer / Senior Validation Engineer

Verista • $70K — $118K *
Saint Louis, MO 63129In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent required
  • 4-6 years of relevant experience
  • Demonstrated experience leading CQV activities specific to Process Equipment
  • Ability to mentor and guide less experienced team members
  • Strong problem-solving and critical thinking skills
  • Experience in a GMP-regulated environment
  • Proficiency in Microsoft Office, particularly WORD advanced features

Responsibilities

  • Design validation plans for projects
  • Conduct and document impact and risk assessments
  • Maintain comprehensive records for compliance audits
  • Design and execute engineering studies for process verification
  • Author and execute technical documentation for qualification and validation
  • Run test scripts and effectively document results
  • Ensure adherence to project schedules for all assigned activities

Benefits

  • High growth potential in a fast-paced, people-focused culture
  • Competitive pay with performance-based incentives
  • Comprehensive insurance offerings including medical, dental, and vision
  • 401(k) plan with employer matching
  • Paid Time Off with rollover options
  • Tuition reimbursement to support continued education
  • Team social activities to foster a fun work environment
Full Job Description
Senior CQV Engineer Responsibilities:
  • Designing validation plans
  • Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
  • Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance 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 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, and complete alarm testing on automated systems
  • Developing, reviewing, and executing testing documentation
  • Making recommendations for design or process modification based on test results when executing test scripts
  • General understanding of capital equipment implementation and process knowledge
  • Understanding validation documents, URS, IQ, OQ, PQ

Requirements:
  • Must be willing to work onsite in St. Louis, MO
  • Bachelor's Degree or equivalent required
  • Ability to mentor and guide less experienced team members
  • Ability to communicate effectively with clients
  • Proven ability to identify areas of business expansion and report to management team for follow-up
  • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
  • 4 - 6 years of demonstrated role relevant experience
  • Demonstrated experience in leading CQV activities specific to Process Equipment
  • Proficiency using PC and Microsoft Office tools
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
  • Ability to work as part of a team
  • Strong problem-solving and critical thinking skills
  • Excellent organizational and time management skills
  • Strong attention to detail
  • GMP and Good Documentation Practice
  • 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
  • Experience with and tolerance for high levels of challenge and change
  • Experience in GMP regulated environment
  • Proven attention to detail and organization in project work
  • Capable of working on assigned tasks without mentorship


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.

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

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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