Validation Specialist III

Swiftwater, PA

Posted: 08/22/2019 Industry: Biotech/R&D/Science Job Number: 49419

Duties:

The candidate will be a member of the Viral Technology team responsible for experimental execution within pilot plant and production areas.  The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures.  Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision.   

Key responsibilities  include: 
  • Responsible  for  authoring and reviewing development and validation notebook studies/ protocols/ reports   
  • Execution of studies in piolet plant / manufacturing  environment 
  • Follow  good documentation practices to record all activities performed and data generated in production of developmental  experiments 
  • Follows  all procedures put into effect to ensure your safety as well as the safety of others.  Participates in safety meetings, reports all safety issues, concerns, incidents and near misses to the team leadership.  
  • Identifies production issues and relays them to the laboratory management.  Ensures all required paperwork is complete, accurate and done in a timely manner to ensure a quality product.  
  • Participation in cross-functional teams, where necessary, to assure correct performance of process operations and working with management to resolve process operations issues. 

Skills:

Preferred  Qualification: 
  • MS  Office 
  • EDoc, with a working knowledge of templates, workflows and approval  process 
  • LabWare/ LIMS experience  preferred 
  • Full  understanding of GMP Documentation and current GMP  standards 
  • Good lab / aseptic technique 
  • To be able to establish  professional working relationships with  other support and production areas  in order to gather  all of  the necessary information required. 
  • Interact well and professionally with a diverse group of  individuals 
  • Self-motivated and willing to be proactive in resolving  issues 
  • Excellent  Verbal and written communication skills.  
  • Ability to work in a team  environment 
  • Ability  to write and complete deviations in a timely and thorough  manner 
  • Ability  to multitask and prioritize  tasks 
  • Flexibility  of hours during execution to include nights and weekends 

Education:

  • Bachelor’ s degree in scientific discipline plus 3-6 years of experience in Vaccine, Biologic, or Pharmaceutical manufacturing and/or development. 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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