Validation Engineer

Pinnaql, Inc.; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is a trusted consulting partner to regulated life sciences companies, delivering deep technical, validation, and quality expertise across the product lifecycle. We seek a Validation Engineer to support CQV activities for facilities, equipment, and processes in GMP-regulated settings, working with cross-functional teams to ensure audit-ready documentation and regulatory compliance.

The successful candidate will have hands-on CQV experience, strong technical writing, and the ability to

Qualifications

• 3+ years of validation, qualification, commissioning, or CQV experience in a regulated life sciences environment.
• Experience in pharmaceutical, biotechnology, medical device, or GMP-regulated industries.
• Strong GMP and validation principles understanding.
• Experience developing or executing validation and qualification protocols.
• Experience with risk-based validation methodologies.
• Strong technical writing and documentation skills.
• Ability to interpret engineering drawings, specifications, procedures, and technical documentation.
• Strong organizational and project management skills.
• Ability to work independently and collaboratively in a project environment.

Responsibilities

• Execute and support CQV activities for regulated life sciences facilities.
• Develop, review, and execute validation documentation (URs, IQ/OQ/PQ, protocols, reports).
• Support qualification of equipment, facilities, utilities, and manufacturing systems.
• Perform protocol execution, data collection, and review qualification results.
• Ensure validation activities meet GMP, FDA, EU GMP standards.
• Participate in risk assessments and apply risk-based validation.
• Support deviations, investigations, CAPA, and change control related to validation projects.
• Review engineering and technical documentation to ensure validation needs are addressed.
• Collaborate with Engineering, QA, Manufacturing, Automation, Facilities, and project stakeholders.
• Track validation deliverables, schedules, open items, milestones.
• Support commissioning activities and transition into formal qualification.
• Ensure validation documentation is complete and audit-ready.
• Participate in client meetings and technical reviews.

Skills

CQV experience

GMP knowledge

Technical writing

Risk-based validation

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science or related

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Engineer

Position Overview

We are seeking an experienced Validation Engineer with Commissioning, Qualification & Validation (CQV) experience to support projects within the life sciences industry. The successful candidate will be responsible for executing and documenting commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, and manufacturing processes in accordance with applicable regulatory requirements and Good Manufacturing Practices (GMP).

This role requires strong technical documentation skills, attention to detail, and the ability to work collaboratively with Engineering, Quality, Manufacturing, Automation, and Project Management teams.

Key Responsibilities

• Execute and support Commissioning, Qualification & Validation (CQV) activities for pharmaceutical, biotechnology, medical device, or other regulated life sciences facilities.
• Develop, review, and execute validation documentation, including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Design/Functional Specifications
  • Commissioning documentation
  • IQ/OQ/PQ protocols and reports
  • Traceability Matrices
  • Summary Reports
• Support qualification of equipment, facilities, utilities, and manufacturing systems.
• Perform protocol execution, field verification, data collection, and review of qualification results.
• Ensure validation activities are performed in compliance with GMP, FDA, EU GMP, and applicable industry standards.
• Participate in FMEA/risk assessments and apply a risk-based approach to validation activities.
• Support deviations, investigations, CAPA, and change control activities associated with validation projects.
• Review engineering and technical documentation to ensure validation requirements are adequately addressed.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, Facilities, and other project stakeholders.
• Track validation deliverables, schedules, open items, and project milestones.
• Support commissioning activities and transition from commissioning into formal qualification.
• Ensure validation documentation is complete, accurate, and audit-ready.
• Participate in client meetings, project status meetings, and technical reviews.
• Provide technical support during regulatory or client inspections, as required.

CQV Experience

Candidates should have hands‑on experience with some combination of:

• Commissioning and qualification of process equipment
• Facility and utility qualification
• Cleanrooms and controlled environments
• HVAC systems
• Purified Water / WFI systems
• Compressed gases and process gases
• Autoclaves, sterilizers, and/or depyrogenation equipment
• Manufacturing and laboratory equipment
• Temperature-controlled systems
• Process systems and supporting utilities
• Equipment and system turnover documentation
• IQ/OQ/PQ execution

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 3+ years of validation, qualification, commissioning, or CQV experience within a regulated life sciences environment.
• Experience working in pharmaceutical, biotechnology, medical device, or other GMP-regulated industries.
• Strong understanding of GMP and validation principles.
• Experience developing and/or executing validation and qualification protocols.
• Experience with risk-based validation methodologies.
• Strong technical writing and documentation skills.
• Ability to interpret engineering drawings, specifications, procedures, and technical documentation.
• Strong organizational and project management skills.
• Ability to work independently and collaboratively in a project environment.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.