Verista

6476 - Service Order CQV Engineer / Validation Engineer

Verista • $70K — $102K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or Science
  • 1-3 years in GMP regulated environment
  • Experience with automated manufacturing equipment
  • Direct experience with validation documents including FAT, IQ, OQ, PQ
  • Knowledge of FDA regulations, ISPE guidelines, and ISO standards
  • Familiarity with ASTM-E2500 standards

Responsibilities

  • Provide CQV expertise on large capital projects
  • Author and execute technical documentation for automated equipment
  • Verify system drawings and electrical schematics
  • Collaborate with clients on deviation investigations
  • Maintain records for compliance audits
  • Adapt project assignments to meet customer requirements

Benefits

  • High growth potential in a fast-paced setting
  • Competitive pay with performance incentives
  • Company-paid Life and Disability Insurance
  • Medical, Dental, and Vision insurance
  • FSA and Commuter Benefits
  • Health Savings Account
  • 401(k) with employer matching
  • Paid Time Off with rollover option
  • Tuition reimbursement
  • Employee recognition and social activities
  • Paid parental leave and bereavement support
Full Job Description
Description

Service Order CQV Engineer Responsibilities:
  • Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation
  • Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards
  • Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support
  • Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits
  • Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope

Requirements:
  • A minimum of a Bachelor's degree in an Engineering or Scientific degree
  • 1-3 years' experience in GMP regulated environment
  • Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
  • Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
  • Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
  • ASTM-E2500


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-$102,623 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

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

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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