Manager, Csv, Manufacturing Systems

1 month ago


Vancouver, Canada AbCellera Full time

AbCellera is transforming antibody drug discovery to bring better medicines to patients more quickly. We are constructing a process development and manufacturing facility in Vancouver, Canada, where our Tech Ops team of scientists and engineers will oversee the manufacturing processes for antibody therapeutics.

AbCellera's engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.

We're offering a generous compensation package including an equity stake in AbCellera's success. Our future facility will be nestled in the heart of Vancouver, Canada - we'll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area

**We'd love to hear from you if**
- You are a passionate leader and critical thinker with the ability to motivate, inspire, and contribute to highly effective teams.
- You are comfortable operating in an evolving, complex, and dynamic environment, and driving against the deliverables of a digital roadmap.
- You are an independent contributor to the design, development and implementation of the CSV/CSA program, to include developing and/or supporting procedures and practices.
- You have strong, hands-on experience with the System Development Lifecycle and the principles of GAMP 5, A Risk-Based Approach to Computer System Validation, 2nd Edition; and the oversight, participation, and execution of risk-based validation activities for QC impacting systems.
- You are enthusiastic about adopting innovative, risk-based strategies for validating Enterprise and Manufacturing impacting systems based on intended, while enabling agile, sustainable compliance.
- You are self-motivated, independent and excel within cross functional teams including IT, Engineering, Manufacturing, Quality Assurance, and additional GxP business process owners.

**How you might spend your days**
- Leading, coaching, mentoring, training and developing cross-functional teams for validation of computerized systems.
- Overseeing and/or participating in validation planning and execution of new software/automation implementations.
- Creating and/or improving computer system validation policies, procedures, templates, and forms.
- Leading and guiding GxP applicability and system assessments tailored for computerized systems.
- Authoring, reviewing and approving qualification/validation documentation and reports.
- Supporting data governance and integrity compliance for computerized systems.
- Reviewing and approving computer system related change controls, discrepancies, deviations, and CAPAs.
- Working closely with vendors to review and provide feedback on vendor validation documentation.
- Providing expertise in CSV compliance, manage identified issues, and support continuous improvement.
- Supporting inspection readiness programs and regulatory agency inspections.
- Developing and evaluating quality processes and system standards to ensure compliance with regulations and standards.

**Required Qualifications and Experience**
- Bachelor's degree in information systems, engineering, or similar technical discipline.
- Minimum 8+ years of experience in Quality Compliance or Computer System Validation roles in Biotech/Pharmaceutical industry.
- Strong knowledge of GAMP principles and Computer Software Assurance.
- Strong knowledge in 21 CFR Part 11, Annex 11, and applicable data integrity requirements.
- Strong understanding of Health Canada, EU, and FDA regulations.
- Knowledge of GCP, GVP, GMP, GDP, and GLP.
- Experience in authoring/reviewing/approving validation documentation.
- Working knowledge of SDLC.
- Experience supporting enterprise software deployments and manufacturing equipment and instruments.
- Experience with vendor audits, system level agreements, and quality agreements.

LI-EM1
LI-DS



  • Vancouver, Canada AbCellera Biologics Full time

    AbCellera is transforming antibody drug discovery to bring better medicines to patients more quickly. We are constructing a process development and manufacturing facility in Vancouver, Canada, where our Tech Ops team of scientists and engineers will oversee the manufacturing processes for antibody therapeutics. AbCellera’s engine integrates expert teams,...


  • Vancouver, Canada AbCellera Biologics Full time

    AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are...

  • Manufacturing Manager

    1 month ago


    Vancouver, Canada Invinity Energy Systems Full time

    Company Description In the world of energy, no area is more exciting than large-scale energy storage. From a few installations a decade ago to a market Barclays Bank says is “likely to approach the trillions,” energy storage makes wind and solar available around the clock. Invinity Energy Systems (LON: IES) **About Us** Invinity is taking a leading...

  • Manufacturing Manager

    4 weeks ago


    Vancouver, Canada Invinity Energy Systems Full time

    Company Description In the world of energy, no area is more exciting than large-scale energy storage. From a few installations a decade ago to a market Barclays Bank says is “likely to approach the trillions,” energy storage makes wind and solar available around the clock. Invinity Energy Systems (LON: IES) **About Us** Invinity is taking a leading...


  • Vancouver, Canada ChopValue Manufacturing Ltd. Full time

    **Job description**: ChopValue’s novel manufacturing process gives recycled chopsticks a second life. The Press Technician plays a vital role in transforming this under-utilized urban waste into an innovative material. In this role, you will be in charge of operating the press that turns chopsticks into raw tiles, as well as maintaining and troubleshooting...


  • Vancouver, Canada Invinity Energy Systems Full time

    Company Description Invinity Energy Systems is a public company trading on the London Stock Exchange with primary operations in Vancouver, Canada. We make large-scale flow battery systems for our global customers. **Job Description**: The Manufacturing Team Leader supports and developes the team and the processes to improve operational and assembly...


  • Vancouver, Canada ChopValue Manufacturing Ltd. Full time

    **ChopValue Manufacturing Technician** ChopValue Manufacturing Ltd. is the world’s first circular economy franchise that manufactures sustainable products made entirely from recycled chopsticks. We are a team of makers, designers and engineers who harvest our urban environment for the most under-utilized resources to create new value-added, innovative...

  • Manufacturing Manager

    1 month ago


    Vancouver, Canada Acel Power Inc Full time

    Education: Bachelor's degree - Experience: 5 years or more - or equivalent experience **Work setting**: - Manufacturing or production **Tasks**: - Read blueprints and drawings - Develop equipment maintenance schedules and recommend the replacement of machines - Develop production schedules and maintain an inventory of raw materials and finished products -...


  • Vancouver, Canada AbCellera Biologics Full time

    AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are...


  • Vancouver, Canada AstraNorth Full time

    Integrating new hardware and complex systems - **Have 8-10 years of Manufacturing Experience across layers - Sensors & Devices, Controls, MES, ERP**: - Have good understanding of S95, S88, 21 CFR P11 - Have deployed Manufacturing Solutions and good understanding Integration Strategy - **Worked on Industrial Communication Protocol - OPCUA, ModBus, MQT,...


  • Vancouver, Canada Wide Naturals Inc. Full time

    **About WIDE Naturals** WIDE Naturals is a health and wellness biotech company focusing on the research and development, production, and sales of natural health products. We are a subsidiary of Innovate Phytotechnologies, Canada’s most forward-thinking group of experts in research, product development, cultivation, strain development and advancement of...


  • Vancouver, Canada STEMCELL Technologies Full time

    **Job Description Summary**: If you are a seasoned professional seeking to lead and optimize manufacturing processes and enjoy working in a highly collaborative and dynamic team environment, then this is the role for you. STEMCELL Technologies is looking for a Manager, Manufacturing, GMP to take the pivotal role of overseeing and directing manufacturing...


  • Vancouver, Canada STEMCELL Technologies Full time

    **Job Description Summary**: Are you a driven and ambitious individual with a passion for science and exceptional time management skills? Are you seeking an opportunity to make a significant impact on cutting-edge biotech manufacturing? If so, we have the perfect opportunity for you! STEMCELL Technologies is looking for a Lab Manager, Manufacturing ISO to...


  • Vancouver, Canada AstraNorth Full time

    **Have 10-15 years of experience in manufacturing domain at Control Layer, MES Layer and ERP Applications Integration**: - Set and manage the technology and operations priorities for the station to achieve business goals - Proactively manage our production environment and take preventative actions/measures to avoid business impacting incidents - Interface...

  • Business Analyst

    1 month ago


    Vancouver, Canada AstraNorth Full time

    Serve as the primary liaison between IT and manufacturing operations team. - Assist in evaluating business needs, research and perform impact analysis of new requirements or changes. - Provide functional and technical support for the OT platform - Architect solutions to solve business problems in the most efficient means possible. - Follow change control...


  • Vancouver, Canada Pantheon Systems, Inc Full time

    We are excited to announce our expansion to **Vancouver, British Columbia, Canada.** This is a rare opportunity for talented professionals to get in on the ground floor and play an instrumental role in shaping the future of our company. If you are driven by excellence, inspired by new challenges, and ready to be a part of a global success story, we invite...

  • production manager

    1 week ago


    Vancouver, Canada Acel Power Inc Full time

    Education: Bachelor's degreeExperience: 5 years or more or equivalent experienceAsset languagesMandarinWork settingManufacturing or productionTasksDevelop production schedules and duty assignments to ensure proper functioningEvaluate daily operations Maintain an inventory of raw materials and finished products to prevent shortagesPlan and organize daily...

  • Systems Specialist

    2 weeks ago


    Vancouver, Canada Dyrand Systems Full time

    **Looking for a Brighter Future? Join Our Team!**: Dyrand Systems believes in being more than just a technology service provider. We want to be a partner to our clients, freeing them from the worries of IT so they can concentrate on the success of their businesses. Our team comes to work every day with that mission in mind, thinking about what they can do to...

  • Systems Specialist

    1 week ago


    Vancouver, Canada Dyrand Systems Full time

    Dyrand Systems believes in being more than just a technology service provider. We want to be a partner to our clients, freeing them from the worries of IT so they can concentrate on the success of their businesses. Our team comes to _work_ every day with that mission in mind, thinking about what they can do to help our clients focus on what they do best. If...

  • production manager

    2 weeks ago


    Vancouver, Canada Acel Power Inc Full time

    Education: Expérience: EducationBachelor's degree or equivalent experienceAsset languagesMandarinWork settingManufacturing or productionTasksDevelop production schedules and duty assignments to ensure proper functioningEvaluate daily operations Maintain an inventory of raw materials and finished products to prevent shortagesPlan and organize daily...