Lead Validation Engineer

Position Title: Senior Validation Engineer

Positions Summary:

Partner with Technology and Business stakeholders to ensure Computerized Systems used in pharmaceutical development are designed, developed, validated/qualified and implemented in compliance with internal processes and agency regulations (GxP requirements, 21 CFR Part 11/Annex 11/GAMP 5) and maintained in a compliant state throughout the lifecycle.

Duties:

• Develop Validation Master Plan, process flow diagrams, tests cases, and execute the validation and qualification activities for infrastructures, applications, networks, instruments, facilities or equipment used in pharmaceutical development and manufacturing

• Author, review and revise installation, operation and performance qualification/verification related documents, including: Standard Operating Procedures (SOPs), validation/verification master plans, guidelines and execution plans, user requirement specifications (URS), Design specifications (DS), functional requirement specifications (FRS) and verification protocols

• Author validation strategies, Risk Assessments, Requirements Traceability Matrices (RTM's), Roles & Responsibilities, Installation Qualifications (IQ's), Operational Qualifications (OQ's), Validation Summary Reports (VSR's), Qualification Summary Reports (QSR), Qualification Project Summary Report, and other validation documents as needed for qualification/verification and/or re-qualification/re-verification

• Create, update and review 'Quality Risk Assessment' documents like System Impact Assessment (SIA), Criticality ssessment (CA) and System Risk Assessment (SRA)

• Perform 21 CFR part 11 testing and CSV testing on the standalone computers and analytical instruments and applications

• Maintain the validated state of GxP computer system applications by performing Change Control, Preventive Maintenance, Periodic Review, Audit Trail, Security and Data Integrity checks

• Plan and execute computerized systems semi/annual maintenance tasks ensuring systems are in compliance with established policies and procedures

• Write and execute qualification/validation test protocols; analyze qualification/ validation test data; draft the deviations/discrepancies and draft summary reports

• Support quality processes and systems across the computerized systems lifecycle including, but not limited to, authoring change control documents, coordinating CAPA activities, and coordinating deviation management and investigation

• Recommend resolution of identified deviations from established product or process standards

• Lead qualification and validation projects; develop project schedule and manage project deliverables

• Generate qualification and validation plans detailing the intended use of the system, scope of work, validation strategy and approach

• Track project progress and provide accurate and timely project status reports to keep projects on track, and in scope

• Review, approve and track system change requests for change implementation/enhancements

• Review and approve Functional Specifications, Design Specifications, and User Manuals and Training records and provide guidance where needed

• Perform/provide guidance on Risk Assessments on computer systems, modules, and individual programs

• Determine validation strategy and scope based on risk assessment results

• Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validated state

• Support internal and external audits and periodic reviews

• Collaborate with business stakeholders on needed SOPs and good documentation practices

• Train new team members on established practices for systems qualification/validation

Qualifications:

• Bachelor's degree in Life Sciences, Computer Science or Computer Information Systems

• Minimum of 6 years in the pharmaceutical industry

• Minimum 8 years of experience in computerized system lifecycle development, systems qualifications / validation of laboratory computerized systems or instruments

• Knowledge of regulatory requirements and standards for using computerized systems (21 CFR Part 11, EU Annex 11, GAMP 5)

• Familiarity with GCP/GLP/GVP/GDP regulations as applied by FDA, EMA, MHRA, HC and PMDA

• Good technical writing skills. Write quality positions, audit reports, and SOPs

• Knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and Power Apps

• Experience in Business Analysis or Project Management is desirable

• Experience with the drug development processes; clinical, non-clinical, pharmacovigilance, or regulatory affairs would be ideal

• Proficiency in applying validation protocols, complex validation processes

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.