Senior Process Engineer / CQV Validation Engineer

Pinnaql, Inc.; United States; On-site; USD 100,000 - 150,000; Full time

Job summary

Validation & Engineering Group in the United States is seeking a Senior Process Engineer CQV Validation Engineer to lead IQ/OQ/PQ activities and drive manufacturing readiness. You will collaborate with Manufacturing Operations, Engineering, Maintenance and Quality to execute validation, perform data analysis, and support CAPAs and change controls, ensuring regulatory compliance and robust processes.

This role is primarily on site with limited remote work, focusing on GMP documentation, protocol

Qualifications

• Minimum 5 years of experience in Process Engineering, Validation, CQV or related.
• Experience with IQ/OQ/PQ protocols and GMP/regulated documentation practices.
• Strong writing, analysis and problem-solving skills.

Responsibilities

• Lead IQ/OQ/PQ protocols and commissioning activities.
• Perform process characterization and capability assessments.
• Support equipment qualification and system verification.
• Collaborate with Manufacturing Operations, Engineering, Maintenance and Quality teams.
• Develop validation summaries, reports and final deliverables.

Skills

Process engineering

Data analysis

Technical writing

Troubleshooting

Job description

Validation & Engineering Group

Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services.

Position

Senior Process Engineer CQV Validation Engineer

Schedule

Approximately 40 hours per week with flexibility to support additional hours when required to meet project milestones validation schedules and manufacturing needs.

Work Model

Primarily on site. Limited remote work may be permitted based on project requirements and management approval.

Key Responsibilities

Process Engineering & Manufacturing Support Lead and execute manufacturing process characterization studiesPerform process capability assessments and data analysisConduct manufacturing line evaluations and performance assessmentsSupport process optimization and continuous improvement initiativesProvide equipment startup troubleshooting and operational readiness supportLead root cause investigations and support implementation of corrective actionsDevelop and execute engineering studies supporting manufacturing objectives and process improvementsCollaborate with Manufacturing Operations Engineering Maintenance and Quality teams

CQV Qualification & Validation Develop and execute IQ OQ and PQ protocolsSupport qualification of new and existing manufacturing equipment and systemsExecute system verification and validation activitiesLead process validation planning execution data analysis and reportingProvide commissioning and qualification supportSupport the full validation lifecycle from planning and protocol development through execution deviation resolution and final report approvalManage protocol deviations exceptions and associated investigationsSupport change control assessments and implementation activitiesDevelop validation summary reports and final project deliverables

GMP Documentation Author revise and support approval of technical documentation including Standard Operating Procedures SOPsBatch RecordsManufacturing InstructionsProcess Evaluation ReportsProcess Characterization Protocols and ReportsProcess Validation Protocols and ReportsEquipment Qualification DocumentationSystem Verification DocumentationEngineering Study Protocols and ReportsRisk AssessmentsTechnical AssessmentsChange ControlsUser Requirements and supporting qualification documentation

Required Qualifications

Minimum 5 years of experience in Process Engineering Validation CQV Manufacturing Engineering or a related disciplineExperience within Medical Device IVD Diagnostics Biotechnology Pharmaceutical or another FDA regulated manufacturing environmentStrong understanding of GMP requirements and regulated documentation practicesDemonstrated experience authoring and executing IQOQPQ protocolsHands on experience with process characterization and process validationExperience supporting equipment qualification and system verificationStrong technical writing and documentation skillsExperience with change controls deviations CAPAs and risk assessmentsStrong analytical troubleshooting and problem solving skillsAbility to independently manage deliverables and collaborate effectively across multiple functional groups

Company Culture

At Validation & Engineering Group 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

Equal Opportunity Employer

Validation & Engineering Group 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