Manufacturing Associate

2 weeks ago

Windsor ON, Canada PEI BioAlliance Full time

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.
This is a full-time permanent position located in Windsor, NS .
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.
Communicating and reporting the status of each project to the management and department that sponsors the project.
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.
Bachelor of Science in Chemistry, Biochemistry, Bioengineering, Biology, Chemical Engineering, or related field.
Statistical analysis tools and methods.
Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. Allqualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenshipstatus, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives,and skills. We value diversity and recognize that experience comes in many forms and skills are transferable.

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