Process Validation Specialist - Diphtheria And Tetanus

Position Title: Process Validation Specialist

Site/Department: Process Validation

Summary of Position:

• Deliver a strong and comprehensive validation program and package for: media/buffer preparation, antigen preparation and adjuvant manufacturing
• Support execution of cleaning validation plans
• Support commissioning and qualification (C&Q) of media and buffer preparation and delivery systems, as well as C&Q of other manufacturing and supporting systems
• Support Process Validation activities and lifecycle management

Key Accountabilities

General:

• Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible
• Support execution phases of the project (validation, start-up, ramp-up) in coordination with Operations, Technical services, Quality and RA
• Assist with the discussions and interactions with the regulatory agencies where required Provide Process Validation expertise for Media and Buffer Process and cP, Dip and Tet

Antigen Processes:

• Ensure operating procedures are current and followed, and site and corporate policies are adhered to
• Filtration validation (fit for use for process conditions, retention, binding, compatibility, etc.)
• Work within the framework of the Manufacturing Technology Team (i.e.: respecting schedule, phase gates, decision processes, design review deadlines, team culture, communication, documents, etc), with professionalism and transparency, and delivering in a timely manner in accordance with the design and execution schedule requirements Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act
• Ensure preparation, review and approval of protocols and reports as per project schedule
• Support development and execution tests for SAT and Qualification of CIP skids and their target systems
• Provide technical risk assessments and gap analysis
• Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible
• Comprehensive mixing studies, establishing validated conditions (duration, mixing speed, temperature, etc.)
• Assist with the discussions and interactions with the regulatory agencies where required Compliance and Safety
• Ensure the project is carried out in a safe manner and safety issues are effectively resolved
• Working closely with C&Q, Automation and Process Engineering leads to support assessment of system integration, flow path sequencing, and recipe development

CONTEXT OF THE JOB/MAJOR CHALLENGES

• Full gowning during manufacturing phase
• May be exposed to pathogens (pertussis, diphtheria, tetanus)

DIMENSIONS/SCOPE

• Key Dimensions: Large biopharmaceutical facility project, with extensive scope and complexity in facility/ automation/process design and qualification, process improvement implementation; effective cross-functional interaction, communication and team management
• Freedom to act, level of autonomy: interface with site management; platform heads, project leaders, global network
• Breadth of Responsibility: Toronto, Canada

Requirements

Education/Certifications

• Sound knowledge in biochemistry and protein chemistry is an asset
• Specialist expertise in process validation including cleaning validation, media and buffer validation and filter validation
• B.Sc, M.Sc or Ph.D Experience
• Strong technical writing is essential
• Good understanding of current regulatory requirements and document preparation
• Excellent communication skills
• Minimum 3-5 years direct experience in biotech pharma/biotech manufacturing, and quality environments in a process validation role

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