Validation Engineer / Specialist

Title: Validation Engineer / Specialist - Reports to Director, Validation

Position Summary

The Validation Engineer / Specialist is a senior technical professional, and part of a team who’s responsible for the completion of all phases of assigned qualification and validation projects ensuring full compliance to regulatory standards and Grifols Canada Therapeutics Inc (GCT) requirements. This position may be involved with only a single aspect or multiple aspects of the following validation areas: utilities and facilities, equipment, automation, process or cleaning validation. This position supports site projects, technical transfer, and ongoing qualification maintenance.

Key Duties and Responsibilities

• Primarily responsible for the design, authorship, and execution of commissioning, qualification and validation studies in any of the following areas:
  • Utilities Qualification (ex. Purified Water, WFI)
  • Facilities Qualification (ex. HVAC and Environmental)
  • Equipment Qualification
  • Automation Qualification (ex. Room Monitoring System, Building Automation System)
  • Process Validation
  • Cleaning Validation
• Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs
• Individual must work on complex assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
• Independently designs, authors, executes and summarizes qualification and validation studies.
• Partners with SMEs to ensure smooth and efficient execution of testing strategies. Develops testing strategies and applies qualification / validation best practices.
• Collaboratively conducts risk and impact assessments.
• Supports development and review of standard operating procedures (SOP) and qualification / validation assessments.
• Calculation and interpretation of data for qualification and validation studies.
• Primary subject matter expert in audits and regulatory agency inspections.
• Supports development of best demonstrated qualification / validation practices within the validation department, based on current industry practices and guidelines.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
• Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to qualification / validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
• Manages successful completion of projects within boundaries of quality, time and budget.
• Based on significant technical expertise, reviews and approves complex design concepts.
• May lead a large-scale project or several small projects with complex features.
• Provide coaching and mentoring to the organization regarding qualification / validation procedures.
• Reviews engineering drawings, design documents and specifications for compliance to GMP/qualification principles and provides feedback to project team for noted deficiencies or improvements.
• Reviews qualification / validation packages for completeness and accuracy, compliance with policies, procedures and accurate data analysis.
• Perform additional duties as assigned

Qualifications

• Education: At minimum, must have a University degree (B. Applied Sc) or B. Engineering in Chemical Engineering.
• A minimum of 8 years of relevant experience in a GMP regulated environment desired. At least 5 years of qualification, validation required.
• Qualification / Validation and/or system experience in at least one of the following applicable areas:
  • Manufacturing systems qualification with technical understanding and experience of automation platforms supporting these systems (SCADA, HMI, PLCs).
  • Sterilization and aseptic process validation
  • Utility and facilities qualification with experience of automation platforms supporting these systems
  • Automated and manual cleaning validation processes
• Ability to effectively lead qualification projects, coordinate junior level personnel and drive results.
• Recognized as expert by peers and other personnel within the business. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
• Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
• Must be able to solve routine problems without assistance.
• Complexity and Problem Solving Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into manageable activities.
• Must possess basic knowledge of core principles in qualification / validation disciplines, as well as be experienced applying project management methodology. Knowledge of basic principles in various engineering disciplines. Internal and External Contacts Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation in support of execution activities. Interaction with project managers for schedule adherence
• Displays general understanding of theories/practices of a variety of disciplines.
• Interfaces with customers on technical issues, project timeline, and qualification support.
• Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Makes independent decisions within defined areas of responsibility.
• Able to multi-task under strict deadlines
• Strong organizational skills, excellent writing and communications skills.
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
• Bilingual in both French and English preferred

Note: Position Title of Utilities Validation Engineer requires engineering designation.