Engineer – Validation Engineer, Specialist 1

• Design, author, execute, and summarize commissioning, qualification, and validation studies.
• Support qualification and validation activities for utilities, facilities, equipment, automation, processes, and cleaning validation.
• Provide technical subject matter expertise for change controls, investigations, deviations, and CAPAs.
• Develop testing strategies and apply qualification and validation best practices.
• Conduct risk and impact assessments collaboratively.
• Support the development and review of SOPs and qualification/validation assessments.
• Calculate and interpret data for qualification and validation studies.
• Serve as a primary subject matter expert during audits and regulatory agency inspections.
• Support the development of qualification and validation practices within the Validation Department.
• Manage projects within quality, schedule, and budget constraints.
• Review and approve complex design concepts, engineering drawings, design documents, specifications, and qualification/validation packages.
• Lead large-scale or multiple complex projects as required.
• Provide coaching and mentoring on qualification and validation procedures.
• Collaborate with manufacturing, scheduling, maintenance, quality personnel, project managers, SMEs, and cross-functional teams.
• Determine root causes and corrective actions for investigation-related issues.
• Perform other duties as assigned.

Requirements

• A minimum of a university degree (BASc) or a Bachelor of Engineering degree in Chemical Engineering is required.
• A minimum of 8 years of relevant experience in a GMP-regulated environment is preferred.
• At least 5 years of qualification and validation experience is required.
• Qualification, validation, and/or systems experience in at least one applicable area: manufacturing systems qualification involving SCADA, HMI, or PLC automation platforms; sterilization and aseptic process validation; utility and facility qualification involving automation platforms; or automated and manual cleaning validation processes.
• Ability to effectively lead qualification projects, coordinate junior personnel, and deliver results.
• Knowledge of industry guidelines, including ISPE and PDA, as well as U.S. and international regulations and standards, including FDA, ICH, ISO, and EU GMP requirements.
• Ability to work independently and in a team environment while interacting with individuals at all organizational and departmental levels.
• Flexibility to respond to shifting priorities and changes in approach in dynamic work environments.
• Ability to solve routine problems independently.
• Excellent analytical skills and systematic problem-solving abilities, including the ability to break down complex problems and tasks into manageable activities.
• Basic knowledge of core qualification and validation principles, with experience applying project management methodologies.
• Knowledge of basic principles across various engineering disciplines.
• Strong organizational skills and excellent written and verbal communication skills.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint; experience with Microsoft Project and Visio is an asset.
• Bilingual proficiency in French and English is preferred; English proficiency is required for documentation and communication with other Grifols sites outside Quebec and Canada.

Core Competencies

Demonstrates expertise in qualification and validation processes, including the ability to design and execute studies, manage projects, and provide technical subject matter expertise in a GMP-regulated environment. Proficient in leading cross-functional teams and ensuring compliance with industry guidelines and regulatory standards.

Highest-signal resume keywords

• Qualification And Validation Experience
• GMP-Regulated Environment Experience
• Project Management Methodologies
• Knowledge Of FDA And EU GMP Regulations
• Bilingual Proficiency In French And English

ATS Optimization Keywords

Hard Skills

• Qualification Studies
• Validation Studies
• Risk And Impact Assessments
• Data Calculation And Interpretation
• SCADA Automation Platforms
• HMI Automation Platforms
• PLC Automation Platforms
• Sterilization Process Validation
• Aseptic Process Validation
• Cleaning Validation Processes

Soft Skills

• Analytical Skills
• Problem-Solving Abilities
• Organizational Skills
• Written Communication Skills
• Verbal Communication Skills

Industry Keywords

• ISPE Guidelines
• PDA Guidelines
• FDA Regulations
• ICH Standards
• ISO Standards

Tools & Technologies

• Microsoft Office
• Microsoft Project
• Microsoft Visio

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