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Commissioning & Qualification Specialist

Birmingham, AL 35211

Posted: 01/10/2024 Job Category: Laboratory Job Number: KG72680102

Job Description

Sirius Staffing is now hiring a Commissioning and qualification Specialist to join a team in Birmingham, AL for a 1-year project. Please see the details below. 

SummaryQualification / Validation Specialists support and execute all phases of assigned projects from concept (R&D) through implementation.  They are required to follow GMP regulatory compliance, and adhere to the site Qualification & Validation Master Plan (QVMP), Standard Operating Procedures (SOPs), and Business Line Policies/Procedures.  During specific tasks and project assignments, the Specialists are expected to follow the guidance of a Lead or Sr. Specialist, as applicable.  This position will work on multi-faceted projects (Capital, Client, and Overhead), supporting multiple tasks/priorities of suitable complexity.

  • Provide support to external departments for tasks that require qualification/validation expertise.
  • Adhere to Plans, SOPs, and Packages ensuring regulatory compliance (FDA/EU) with industry standards, practices, and trends.
  • Prepare Qualification / Validation Packages (Protocols and Summary Reports) within the assigned/specified area/project ensuring the results/conclusions are accurate and in compliance with Site Plans, Business Line Policies, and Procedures
  • Establishes safety as the number one priority through training, actions, and behaviors.
  • Adhere to the Company’s safety, health and environmental policies, procedures, and directives.
  • Strong problem-solving and critical thinking skills with demonstrated ability to execute technical programs to achieve established goals; strong organization skills to multiple tasks at differing levels of complexity
  • Bachelor’s degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
  • Minimum of 3 years working in the Pharmaceutical Industry performing Qualifications / Validations for new or modified systems
  • Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices (GAMP), and cGMPs 
  • Knowledge/hands-on experience in the setup and operation of Kaye Validator systems.
  • Knowledge/exposure to aseptic pharmaceutical manufacturing process/production/facilities
  • Knowledge of Aseptic techniques and cleanroom requirements
Sirius Staffing is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.

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Bailee Stevens

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