Process Validation Associate - Windsor, Canada - BioVectra Inc.

BioVectra Inc.

Verified Company

Windsor, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

BIOVECTRA Inc.

is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BIOVECTRA Inc. has an opening for a
Process Validation Associate. This is a full-time permanent position located in
Windsor, NS.

Assisting in the establishment of the tech transfer, scale up, and validation strategy for new processes/equipment and translates those requirements to appropriate validation protocols and standard operating procedures.
Working with the Process Development Group to ensure appropriate critical process parameters are implemented, justified, and measured to control the process critical quality attributes.
Identifying potential scale up obstacles and working with Engineers, Quality Assurance, Process Development and Manufacturing professionals to ensure validation risks are mitigated and controlled.
Leading participant in conducting process risks analysis and process hazard analysis.
Developing, maintaining, and updating the Validation Master Plan (VPM) for the overall project.
Qualification of new equipment/processes, computerrelated system qualification and calibration program management.
Reviewing detailed plant layouts, procedures, and equipment specifications (URS) to ensure the project progress and quality / regulatory compliance.
Conducting and/or participating in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA), maintaining compliance within the company.
Communicating and reporting the status of each project to the management and department that sponsors the project.
Working as part of a multidisciplinary team.
Reviewing and updating Standard Operating Procedures to ensure appropriate content.
Providing technical expertise and oversight on various technical documents (BPR's, New Product Validation Reports, etc.).
Assisting in multiple complex technology transfer projects related to the manufacturing and testing.
Authoring and reviewing technical documents including standard operating procedures, testing protocols, technical reports, batch files and technical transfer documents.
Adhering to BioVectra's Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
Additional duties assigned, based on business needs and the department supervisor's request.
Bachelor of Science in Chemistry, Biochemistry, Bioengineering, Biology, Chemical Engineering, or related field.
Three years GMP pharmaceutical processing experience.
Statistical analysis tools and methods.