The Process Validation Engineer is a senior technical professional, responsible for the completion of all phases of assigned qualification and validation projects ensuring full compliance to regulatory standards and Green Cross Biotherapeutics (GCBT) requirements. This position supports site projects, technical transfer, and ongoing validation maintenance.
Key Duties and Responsibilities
- Primarily responsible for the design, authorship, and execution of process validation protocols to support manufacturing of plasma-derived therapies.
- Actively completing, coordinating and managing all phases of assigned process validation activities including but not limited to:
- Development and review of engineering study protocols, engineering run protocols and process validation protocols to support PPQ / PV requirements and program at Green Cross Biotherapeutics.
- Development, review and/or QV approval of all related process validation documentation.
- Provides technical subject matter expert (SME) support to change controls, investigations, deviations and CAPAs related manufacturing process
- 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 process validation studies.
- Partners with SMEs to ensure smooth and efficient execution of testing strategies. Develops testing strategies and applies validation best practices.
- Collaboratively conducts risk and impact assessments.
- Supports development and review of standard operating procedures (SOP) and validation assessments.
- Calculation and interpretation of data for process validation studies.
- Primary subject matter expert in audits and regulatory agency inspections.
- Supports development of best demonstrated validation practices within the quality 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 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 and validation staff regarding process validation procedures.
- Reviews process validation packages for completeness and accuracy, compliance with policies, procedures and accurate data analysis.
- Perform additional duties as assigned
- Education: At minimum, must have a University degree (B Sc) in Chemistry, Biology or life science. (Validation Specialist)
- A minimum of 6 years of relevant experience in a GMP regulated environment desired. At least 5 years of commissioning, qualification and validation (CQV) required. At least 2 years of personnel supervision experience or project management experience desired.
- Validation and/or system experience in the following applicable areas: Sterilization and aseptic processing validation. process validation, technology transfer, process engineering. Technical understanding and experience with automation platforms.
- Ability to effectively lead validation projects, coordinate junior level personnel and drive results.
- Direct experience with 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 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 validation 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
Job Type: Full-time
- English (Required)
- French (Required)