Validation Engineer

Pinnaql; United States; On-site; USD 110,000 - 140,000; Full time

Job summary

Pinnaql in the United States seeks an experienced Validation Engineer with CQV expertise to support life sciences projects. You will execute and document commissioning, qualification and validation activities for facilities, utilities, equipment and processes in compliance with GMP and regulatory standards.

Collaborate with Engineering, Quality, Manufacturing and Project Management to deliver audit-ready validation packages and support inspections.

Qualifications

• Candidates should have hands-on CQV experience and strong GMP knowledge.
• Experience developing or executing validation/qualification protocols in regulated environments.
• Ability to interpret engineering drawings and technical documentation.

Responsibilities

• Execute and support CQV activities for life sciences facilities and equipment.
• Develop and review validation documentation including plans, URS, risk assessments, IQ/OQ/PQ protocols.
• Track deliverables and ensure audit-ready documentation.

Skills

CQV experience

Validation

Technical writing

Project management

GMP knowledge

Education

Bachelor's degree in Engineering or Science

Tools

IQ/OQ/PQ protocols

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 EngineerPosition 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 facilitiesDevelop review and execute validation documentation includingValidation PlansUser Requirements Specifications URSRisk AssessmentsDesignFunctional SpecificationsCommissioning documentationIQOQPQ protocols and reportsTraceability MatricesSummary ReportsSupport qualification of equipment facilities utilities and manufacturing systemsPerform protocol execution field verification data collection and review of qualification resultsEnsure validation activities are performed in compliance with GMP FDA EU GMP and applicable industry standardsParticipate in FMEArisk assessments and apply a risk based approach to validation activitiesSupport deviations investigations CAPA and change control activities associated with validation projectsReview engineering and technical documentation to ensure validation requirements are adequately addressedCollaborate with Engineering Quality Assurance Manufacturing Automation Facilities and other project stakeholdersTrack validation deliverables schedules open items and project milestonesSupport commissioning activities and transition from commissioning into formal qualificationEnsure validation documentation is complete accurate and audit readyParticipate in client meetings project status meetings and technical reviewsProvide technical support during regulatory or client inspections as requiredCQV Experience Candidates should have hands on experience with some combination of Commissioning and qualification of process equipmentFacility and utility qualificationCleanrooms and controlled environmentsHVAC systemsPurified Water WFI systemsCompressed gases and process gasesAutoclaves sterilizers andor depyrogenation equipmentManufacturing and laboratory equipmentTemperature controlled systemsProcess systems and supporting utilitiesEquipment and system turnover documentationIQOQPQ executionRequired Qualifications Bachelors degree in Engineering Science or a related technical discipline3 years of validation qualification commissioning or CQV experience within a regulated life sciences environmentExperience working in pharmaceutical biotechnology medical device or other GMP regulated industriesStrong understanding of GMP and validation principlesExperience developing andor executing validation and qualification protocolsExperience with risk based validation methodologiesStrong technical writing and documentation skillsAbility to interpret engineering drawings specifications procedures and technical documentationStrong organizational and project management skillsAbility to work independently and collaboratively in a project environmentAt Pinnaql people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you 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

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

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 youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you 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