6490 - Senior C&Q Engineer / Senior Validation Engineer

Openkrill; United States; Teletrabalho; USD 79 000 - 114 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) Matching

Paid Time Off

Life Insurance

Health Insurance

Dental & Vision

Tuition Reimbursement

Parental Leave

Resumo da oferta

Verista seeks a Senior Validation Engineer to lead Commissioning & Qualification programs for GMP facilities and manufacturing systems. You will develop and execute validation protocols, manage risk-based qualification strategies, and ensure documentation quality across global projects.

The role emphasizes cross-functional collaboration with Engineering, Quality, and Operations, with remote work options and limited travel to client sites.

Qualificações

• Bachelor's degree in Engineering, Life Sciences or related field.
• 5+ years in C&Q, commissioning, qualification, or validation in regulated environments.
• Hands-on experience with GMP facilities, utilities, equipment, or systems.
• Strong knowledge of CMP/verification deliverables and lifecycle management.

Responsabilidades

• Lead C&Q activities for GMP facilities and manufacturing systems across the project lifecycle.
• Develop and execute URS, risk assessments, DQ, IQ/OQ/PQ protocols and reports.
• Coordinate field execution, punch-list management, deviations, and closeout.
• Maintain Q&Q documentation using electronic systems and ensure compliance.

Conhecimentos

C&Q/CQV

GMP

Kneat

Documentation

Cross-functional

Project mgmt

Validation

Formação académica

Bachelor’s degree in Engineering or Life Sciences

Ferramentas

HP ALM/Quality Center

Jira

Documentum

Veeva Vault

Descrição da oferta de emprego

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

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.

*Verista is an equal opportunity employer.

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

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