Specialist, Process Validation

3 weeks ago

Montréal, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Center (BMC) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences industry and fosters industry development and innovation through Canadian production. Backed by a committed and innovative team of employees, the BMC fosters a culture of agility and transparency, with a collaborative, results-oriented approach.

The BMC is seeking a **Process Validation Specialist** who will contribute to the technology transfer department by being responsible for the validation lifecycle of cleaning methods, aseptic processes, and manufacturing processes.

Under the supervision of the Director, Technology Transfers, the **Process Validation Specialist **will have the following responsibilities:

- Be responsible for the validation of:

- cleaning and sterilization methods,
- aseptic process simulations (media fill),
- manufacturing processes (Purification, Cell culture),
- filling and secondary and final packaging.
- Establish the validation strategy in collaboration with the Manufacturing Sciences team.
- Plan the validation project in collaboration with the Project Management team.
- Write and revise validation protocols and coordinate their approval, including protocols from suppliers.
- Plan, coordinate, and execute the required validation tests and document them.
- Write non-conformity reports and ensure their resolution.
- Authorize the transition to a subsequent qualification phase.
- Compile documentation and write closure reports.
- Coordinate and guide the activities of external validation consultants.
- Participate in the evaluation or implementation of change controls and corrective and preventive actions.
- Participate in revalidation and requalification.
- Participate in regulatory audits.
- Write and maintain procedures related to their activities.
- Manage validation documentation: prepare equipment files, assign numbering, and archive according to the current procedure.
- Write risk analyses.

**You are the person we are looking for if**:

- You hold a university degree in science or engineering in an appropriate discipline (chemical engineering or equivalent).
- You have 5 years or more of GMP experience in a validation position in the pharmaceutical or biotechnological industry.
- You have experience in writing, revising, and executing validation protocols, as well as with the use of protocols from suppliers.
- You have experience in validation of cleaning, decontamination processes, and sterilization processes.
- You have good communication skills in French.
- You are able to communicate orally and in writing in English as some suppliers are out of province.
- You have knowledge of investigation processes, deviations, change control, and CAPA.
- You reside in the province of Québec.

**The BMC, an employer offering what's important to you**
- A flexible schedule and work mode hybrid
- A culture of transparency, notably with our monthly corporate meetings
- A respectful and friendly work environment
- A new building with state-of-the-art equipment
- A competitive salary commensurate with your skills
- An attractive vacation and leave program
- A group RRSP with a generous contribution from the BMC
- A comprehensive insurance plan including telemedicine
- An opportunity to participate in our various life committees (social club, employee committee, OHS committee, etc.)
- A host of activities throughout the year to socialize with your colleagues, recognize team successes and improve your knowledge.
- Free on-site parking.

**The BMC, an organization like no other**
- Our team is made up of talented, committed individuals with diverse backgrounds.
- We aim to develop, share and transmit knowledge
- Our NPO status enables us to reinvest every dollar of profit back into the organization
- Our human scale empowers all our employees to participate in driving the company forward
- Our economic positioning is unique in our industry
- Our social mission is extraordinary

**The BMC, a key player in Canadian biotech production**

The BMC is a new facility in the heart of Montreal, completed in June 2021. It supports the growth of the country's biologics production capacity, ensuring that vaccines and other related products can be manufactured safely, right here at home. Thanks to its state-of-the-art facilities and the knowledge of its team, the BMC can produce biopharmaceutical products such as viral vector, protein subunit and virus-like particle vaccines, as well as other biological products. It is a key player in Canada's ability to respond rapidly to future national and global health emergencies

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