Process Validation Specialist - Toronto, Canada - Zany Consulting Group

Zany Consulting Group

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Position Titl

e:
Process Validation Specialist

Site/Department:
Process Validation

Summary of Position:

Support Process Validation activities and lifecycle management
Deliver a strong and comprehensive validation program and package for: media/buffer preparation, antigen preparation and adjuvant manufacturing
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 execution of cleaning validation plans

Key Accountabilities

General:

Support execution phases of the project (validation, startup, rampup) in coordination with Operations, Technical services, Quality and RA
Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible
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:

Comprehensive mixing studies, establishing validated conditions (duration, mixing speed, temperature, etc.)
Filtration validation (fit for use for process conditions, retention, binding, compatibility, etc.)
Ensure preparation, review and approval of protocols and reports as per project schedule
Provide technical risk assessments and gap analysis
Working closely with C&Q, Automation and Process Engineering leads to support assessment of system integration, flow path sequencing, and recipe development
Support development and execution tests for SAT and Qualification of CIP skids and their target systems
Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible
Assist with the discussions and interactions with the regulatory agencies where required Compliance and Safety
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 operating procedures are current and followed, and site and corporate policies are adhered to
Ensure the project is carried out in a safe manner and safety issues are effectively resolved

CONTEXT OF THE JOB/MAJOR CHALLENGES

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

DIMENSIONS/SCOPE

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

REQUIREMENTS:

Education/Certifications

B.Sc, M.Sc or Ph.

D Experience

Minimum 35 years direct experience in biotech pharma/biotech manufacturing, and quality environments in a process validation role
Specialist expertise in process validation including cleaning validation, media and buffer validation and filter validation
Sound knowledge in biochemistry and protein chemistry is an asset
Strong technical writing is essential
Excellent communication skills
Good understanding of current regulatory requirements and document preparation

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