Verista

6490 - Senior C&Q Engineer / Senior Validation Engineer

Verista • $78K — $113K *
US-AnywhereRemote in Devens, MA
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant industry discipline
  • 5+ years of experience in regulated life sciences systems
  • Hands-on experience with user acceptance testing (UAT)
  • Knowledge of Good Documentation Practices (GDP)
  • Strong writing, organizational, and communication skills
  • Ability to handle multiple priorities in a global team environment
  • Experience with digital validation solutions preferred

Responsibilities

  • Support development of UAT scope and test scenarios
  • Coordinate execution of UAT and defect tracking
  • Draft and update Standard Operating Procedures (SOPs) and templates
  • Format documents adhering to client standards
  • Assist with digitization of document libraries
  • Develop training materials and user communications
  • Maintain deployment-readiness trackers for various aspects of project management

Benefits

  • High growth potential in a fast-paced, people-focused culture
  • Performance-based incentives alongside competitive pay
  • Company-paid life and disability insurance
  • Comprehensive medical, dental, and vision coverage
  • 401(k) retirement plan with employer matching
  • Paid time off with rollover option
  • Tuition reimbursement and team social activities
Full Job Description
Senior Validation Engineer Responsibilities:
  • Lead and support Commissioning & Qualification (C&Q/CQV) activities for GMP facilities, utilities, equipment, and manufacturing systems throughout the project lifecycle.
  • Develop, review, and execute C&Q deliverables including URS, risk assessments, DQ, FAT/SAT, commissioning test plans, IQ/OQ/PQ protocols, traceability matrices, and qualification summary reports.
  • Coordinate C&Q execution activities, including protocol scheduling, field execution, test evidence collection, punch-list management, discrepancy/deviation resolution, retesting, and final documentation closeout.
  • Support development and implementation of risk-based qualification strategies in accordance with GMP requirements, ASTM E2500, GEP, and applicable site/client procedures.
  • Author, review, and update C&Q procedures, protocols, work instructions, commissioning documents, test scripts, templates, and qualification reports in accordance with Good Documentation Practices.
  • Manage C&Q documentation through electronic document management and digital qualification platforms, ensuring proper formatting, metadata, traceability, approvals, and document lifecycle control.
  • Support digital C&Q execution and documentation, including configuration and use of Kneat or similar C&Q/validation platforms, electronic protocols, test evidence, workflows, and qualification records.
  • Coordinate with Engineering, Automation, Quality, Operations, Maintenance, Facilities, IT, Subject Matter Experts, site teams, and external vendors to ensure C&Q activities are aligned with project schedules and operational requirements.
  • Maintain C&Q project trackers covering protocol status, execution progress, open actions, punch-list items, deviations, documentation readiness, system turnover, and qualification closeout.
  • Support facility and equipment turnover, commissioning completion, qualification readiness, and operational handoff to site teams.
  • Provide clear status updates on C&Q progress, schedule, risks, issues, dependencies, and outstanding actions to project and site leadership.
  • Support inspection and audit readiness by ensuring C&Q documentation is complete, traceable, technically justified, and compliant with applicable GMP requirements.
  • Support multiple concurrent C&Q projects and priorities while maintaining quality, schedule, and documentation requirements across a global, cross-functional organization.

Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or another industry-related technical discipline.
  • 5+ years of experience in C&Q/CQV, commissioning, qualification, validation, engineering, or technical project execution within regulated pharmaceutical, biotech, or life sciences environments.
  • Demonstrated hands-on experience with commissioning and qualification of GMP facilities, utilities, equipment, manufacturing systems, or laboratory systems.
  • Strong working knowledge of C&Q methodologies and deliverables, including URS, DQ, FAT/SAT, commissioning, IQ/OQ/PQ, traceability, risk assessments, deviations, and qualification summary reports.
  • Working knowledge of GMP, GEP, ASTM E2500, risk-based qualification, and Good Documentation Practices.
  • Kneat Power User Level 1 (or higher) certification highly preferred, with hands-on experience using Kneat or similar digital C&Q/validation platforms.
  • Experience authoring, reviewing, and executing C&Q protocols, test scripts, commissioning documents, qualification reports, SOPs, work instructions, and other controlled documentation.
  • Experience coordinating field execution with Engineering, Quality, Operations, Automation, Maintenance, vendors, and other cross-functional stakeholders.
  • Familiarity with punch-list management, discrepancy/deviation resolution, change control, turnover, system handoff, and C&Q closeout activities.
  • Strong understanding of requirements traceability, test evidence, documentation workflows, and qualification lifecycle management.
  • Experience with HP ALM/Quality Center, Jira, or other project/test-management platforms preferred.
  • Experience with BMS, Documentum, Veeva Vault, or other electronic document management systems preferred.
  • Experience supporting large-scale pharmaceutical/biotech capital projects, facility expansions, equipment installations, or multi-site C&Q programs preferred.
  • Strong written and verbal communication, organizational, problem-solving, and stakeholder-management skills.
  • Ability to manage multiple priorities and work independently within a global, cross-functional project environment
  • This role is remote; limited travel to client sites may be requested with advance notice.


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

$78,925-$113,521 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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