Manager Process Validation

2 weeks ago

Windsor, Canada BioVectra Inc. Full time

**Manager Process Validation**
Windsor, NS, Canada Req #1104
Date Posted: February 6, 2023

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 **has an opening for a** Manager Process Validation** This is a** permanent, full-time** position located in** Windsor, NS.**
- Establishing 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, computer-related 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 multi-disciplinary team.
- Reviewing and updating Standard Operating Procedures to ensure appropriate content.
- Ensuring employee's training is performed and maintained.
- Coaching and conducting performance reviews from the team.
- Ensuring that the Validation department meets budget provided by Senior Management.
- Providing technical expertise and oversight on various technical documents (BPR's, New Product Validation Reports, etc.).
- Developing staff regarding teamwork, validation techniques and procedures to ensure cGMP compliance.
- Managing 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.
- Bachelor of Science in Chemistry, Biochemistry, Bioengineering, Chemical Engineering, or related field.
- Five years pharmaceutical industry experience.
- Statistical analysis tools and methods.

**Closing Date: February 24, 2023

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