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Grifols Shared Services North America, Inc Validation Engineer/Specialist (Environmental) in Montreal, Canada

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Position Title: Environmental Validation Engineer / Specialist

Reports to: Sr. Manager, Validation

Position Summary

The Environmental Validation Engineer / Specialist is a senior technical professional, responsible for the completion of all phases of assigned Environmental qualification and validation projects ensuring full compliance to regulatory standards and Grifols Canada Therapeutics Inc (GCT) requirements. This position supports site projects, technical transfer, and ongoing qualification maintenance. This position will work closely with the Utilities Validation Engineer / Specialist.

Key Duties and Responsibilities

  • Primarily responsible for the design, authorship, and execution of environmental qualification studies for Facilities, and Utilities equipment.

  • Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs related to environmental analysis of Facilities and Utilities equipment.

  • 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 environmental commissioning, qualification studies.

  • Partners with SMEs to ensure smooth and efficient execution of testing strategies. Develops testing strategies and applies qualification best practices.

  • Collaboratively conducts risk and impact assessments.

  • Supports development and review of standard operating procedures (SOP) and qualification assessments.

  • Calculation and interpretation of data for commissioning, qualification studies.

  • Primary subject matter expert in audits and regulatory agency inspections.

  • Supports development of best demonstrated qualification 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 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 and qualification staff regarding commissioning, qualification, verification and related qualification 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 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 commissioning, qualification (CQ) of environmental validation of Facilities and Utilities system required. At least 2 years of personnel supervision experience or project management experience desired.

  • Qualification and/or system experience in the following applicable areas: Utility systems qualification with technical understanding and experience of automation platforms supporting Utility systems.

  • Ability to effectively lead qualification projects, coordinate junior level personnel and drive results.

  • Direct experience with utility systems for manufacturing operations and biotechnology processes is strongly desired. Cross-functional team experience

  • 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 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 Environmental Validation Engineer requires engineering designation.

Req ID: 334552_1

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