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Senior Validation Specialist

4 months ago

Cranbury, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
  • pplies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.
  • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
  • Familiarity with 21 CFR Part 11 compliance.
  • Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
  • Experience executing equipment qualification documents.
  • bility to interact effectively with laboratory, QA, and Facilities groups.
  • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
  • Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
Requirements:
  • Direct experience with writing and executing validation protocols is preferred.
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Good interpersonal/communication/influencing/negotiation skills.
  • Strong project management skills
  • bility to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
  • Direct or indirect industry knowledge.
  • bility to work independently or in teams.
  • BS Degree in Science, Engineering or Math with at least one or more years of experience.
  • Minimum 5 years of experience in FDA - regulated industry, with 3 years of experience in equipment qualification and computer system validations.