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New Beta Innovation Canada Limited

Senior Specialist, Validation

Details
Full Time
5 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI-CA) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.

Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.

POSITION OVERVIEW

Reporting to the Manager, Validation/ Senior Manager, Compliance, the incumbent will perform a variety of Validation related functions to contribute to the creation and implementation of the Validation program for sterile bio-pharmaceutical product manufacturing and aseptic filling.

Key Responsibilities

  • Prepare and review commissioning, qualification and validation documents of equipment, utilities, facility and processes with the focus on cGMP compliance in collaboration with other validation personnel and user departments – including but not limited to – URS, DQ, FDS, FAT/SAT, IOQ, PQ, validation plan, risk assessment, validation summary report, SOPs, cleaning validation, computer system validation (CSV), requalification, process validation etc.
  • Lead E&M and Facility equipment validation program and review all validation documents in the validation lifecycle to ensure compliance
  • Responsible for validation execution collaboration and oversite for Engineering & Maintenance (E&M) and Facility area
  • Responsible for various QMS tasks including but not limited to - validation change control, deviation, investigations, CAPA, etc.
  • Lead periodic review and requalification program of E&M and Facility systems
  • Perform audit trail review and computerized system management (CSM) activities for all E&M and Facility systems
  • Review computer systems validation (CSV), SOPs, policies and qualification documents
  • Lead software validation and CSV for E&M and Facility systems
  • Support Engineering & Maintenance to set up a preventive maintenance and calibration program to ensure compliance with GMP requirements, and perform validation oversight on calibration and maintenance activities
  • Support the setup and maintenance of other validation programs and activities including – process, method, cleaning, transportation, computer system validation
  • Support other Production and QC qualification activities as required
  • Perform other duties as required

Knowledge, Skills and Experience

  • Degree in Life Sciences or relevant major
  • A minimum of 5 years of work experience in pharmaceutical or biologics manufacturing industry
  • Minimum 3 years of direct validation experience in commissioning, equipment and facility qualification is preferred
  • Proven knowledge and experience in applying the risk-based approach throughout the validation lifecycle
  • Good knowledge of GMP and QMS principles
  • In-depth understanding of validation requirements in the regulation and guidelines
  • Knowledge and experience with aseptic processing is desirable
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Working efficiently with the ability to be innovative and identify creative solutions
  • High proficiency in MS Word/Excel and good writing skills
  • Strong sense of pride in ownership of, attention to detail and quality of work

WHY JOIN NBI?

The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.

Category
Manufacturing and Production Quality Assurance

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About New Beta Innovation Canada Limited

New B Innovation (NBI) is a dedicated player in the global biotechnology market with a vision to advance life sciences and health care using the latest technologies and innovative approaches to del...

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Industry
Technology
Size
51-200 employees