Senior Process Engineer / CQV Validation Engineer

Validation & Engineering Group; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group seeks a Senior Process Engineer CQV Validation Engineer to lead manufacturing process characterization and validation activities. The role focuses on IQ/OQ/PQ execution, equipment qualification, and continuous improvement in a primarily on-site setting with potential limited remote work based on project requirements.

Candidates should have 5+ years in process engineering/validation, strong GMP documentation practices, and experience with CAPAs and risk assessments.

Qualifications

• 5+ years in Process Engineering, Validation or CQV within FDA-regulated environments.
• Experience in Medical Device, Diagnostics, Biotechnology, Pharmaceuticals or similar sectors.
• Strong GMP documentation practices and writing skills.
• Experience with CAPAs, deviations and risk assessments.
• Ability to lead cross-functional teams and manage deliverables across departments.

Responsibilities

• Lead and execute manufacturing process characterization studies.
• Perform process capability assessments and data analysis.
• Support process optimization and continuous improvement initiatives.
• Lead root cause investigations and CAPA implementations.
• Coordinate IQ/OQ/PQ protocols and equipment qualification.
• Collaborate with Manufacturing, Operations, Engineering, Maintenance and QA teams.

Skills

Process validation

IQ/OQ/PQ protocols

GMP compliance

Process characterization

Root cause analysis

Technical writing

Equipment qualification

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