Job Description

Req #1304

Wednesday, August 2, 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 Pharmaceutical Process Validation This is a permanent, full-time position located in Charlottetown, PEI.

The candidate will be responsible for:

• 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.

The successful candidate for this position should have:

• Bachelor of Science in Chemistry, Biochemistry, Bioengineering, Chemical Engineering, or related field.
• Five years pharmaceutical industry experience.
• Statistical analysis tools and methods.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the \xe2\x80\x9cApply Now\xe2\x80\x9d button.

Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, 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. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply! We thank all interested parties; however, only those applicants considered for an interview will be contacted.

Other details

• Pay Type Salary

BioVectra