Senior Validation Engineer

TekWissen ®; Bend (OR); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

TekWissen is seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities within a pharmaceutical / biotechnology environment.

The role focuses on ensuring compliance with GxP requirements, applicable regulations, and industry standards while promoting Data Integrity (DI), maintaining validation documentation, supporting inspections, and driving

Formación

• Bachelor's degree in science or related field.
• Minimum of five years in pharma/biotech with at least two in a Quality Unit.
• Experience in equipment and analytical instrument qualification.
• Experience with computerized systems validation (CSV).
• Working knowledge of GxP requirements and relevant standards.

Responsabilidades

• Support commissioning, qualification, and computerized system validation projects.
• Prepare, execute, review, and approve validation protocols, reports, and lifecycle docs.
• Collaborate with IT, QC, Automation, QA, and vendors to review activities.
• Perform change management and risk assessments.
• Provide SME input and ensure consistent validation strategies for systems and methods.
• Support troubleshooting, investigations, CAPA, and training.
• Participate in client and regulatory inspections.
• Promote Data Integrity and drive site DI maturity improvements.

Conocimientos

Data Integrity

Validation

GxP Knowledge

Regulatory Compliance

Cross-functional

Documentation

CAPA

Problem Solving

Educación

Bachelor's degree in science

Herramientas

CSV

Descripción del empleo

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Summary

We are seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities within a pharmaceutical / biotechnology environment. The role focuses on ensuring compliance with GxP requirements, applicable regulations, and industry standards while promoting Data Integrity (DI), maintaining validation documentation, supporting inspections, and driving continuous improvement across site operations.

Responsibilities

• Support commissioning, qualification, and computerized system validation projects.
• Prepare, execute, review, and approve validation protocols, reports, and system lifecycle documentation.
• Collaborate with IT, Quality Control (QC), Automation, Quality Assurance (QA), and vendors to review and approve qualification and validation activities.
• Perform change management and risk assessments.
• Provide subject matter expertise and ensure consistent validation strategies for equipment, systems, computerized systems, and methods.
• Support system troubleshooting, staff training, investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Participate in client and regulatory inspections.
• Promote Data Integrity awareness and support improvements in site Data Integrity maturity.
• Establish and facilitate Data Integrity forums to share best practices, review remediation activities, discuss training, and address potential Data Integrity risks.
• Conduct regular Data Integrity GEMBA walkthroughs.
• Generate, review, and approve controlled documents and records.
• Oversee validation activities, support problem resolution, and make decisions related to commissioning, qualification, and validation.
• Collaborate with stakeholders to resolve findings and reduce potential Data Integrity risks identified through assessments and gap analyses.

Required Skills and Qualifications

• Bachelor's degree in science or a related discipline.
• Minimum of five years of experience in the pharmaceutical, biotechnology, or related industry, including at least two years in a Quality Unit.
• Experience in equipment and analytical instrument qualification.
• Experience with computerized systems validation (CSV).
• Working knowledge of GxP requirements, 21 CFR Part 11, EU GMP Annex 11, and relevant industry standards such as USP.
• Knowledge of commissioning, qualification, and validation processes, including validation documentation and system lifecycle management.
• Understanding of change management, risk assessments, Data Integrity principles, investigations, root cause analysis, and CAPA.
• Strong cross-functional collaboration, technical troubleshooting, documentation, and problem-solving skills.
• Ability to support regulatory inspections, validation oversight, and continuous improvement initiatives.
• Ability to wear personal protective equipment (PPE), perform occasional light lifting of less than 25 lbs, and travel as needed.

TekWissen Group is an equal opportunity employer supporting workforce diversity.