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Specialist, Validation

Location
Burnaby, BC
Details
Full Time
3 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 Assistant Manager/ Manager, Validation, the incumbent will perform a variety of Validation related functions to contribute to the creation and implementation of the Validation program at NBI-CA 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, etc.
  • Support in maintaining the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance
  • Support and collaborate execution of validation activities with user departments. Provide oversight to validation activities execution with user departments  
  • Responsible for various QMS tasks including but not limited to - validation change control, deviation, investigations, CAPA, etc.
  • Support and collaborate periodic review and requalification program of all GMP systems
  • Support to maintain track records of all audit trail review and computerized system management (CSM) activities for all GMP systems
  • Collaborate with other departments for alarm handling, data trending and other statistical data analysis   
  • Support to review validation documents and ensure compliance to regulations and guidelines
  • Maintain validation schedules, system periodic review schedule and CSV inventory list
  • Work closely with other departments to achieve project deliverables
  • Perform other related tasks as needed

KNOWLEDGE, SKILLS AND ABILITIES     

  • Degree in Life Sciences or relevant major
  • Minimum 3 years validation relevant work experience in pharmaceutical or biologics manufacturing industry
  • Good knowledge of GMP and QMS principles
  • In-depth understanding of validation requirements in the regulation and guidance
  • Knowledge and experience in applying the risk-based approach throughout the validation lifecycle is an asset
  • Knowledge and experience with aseptic processing is an asset
  • 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 suite and good writing skills
  • Strong sense of pride in ownership of, and quality of work
  • Attention to detail

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. 

If you are interested in joining our team, we encourage you to APPLY today!    

Category
Biotechnology