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Commissioning & Qualification Technician

Birmingham, AL 35211

Posted: 02/28/2023 Job Category: Engineer Job Number: KG579059130

Job Description

Sirius Staffing is seeking a Commissioning and Qualification Technician for a temp to possible permanent position in Birmingham, Alabama. 
  • Adhere to all company safety, health and environmental policies, procedures and directives.
  • Follows internal SOP’s and cGMP regulations. Generate and maintain thorough and accurate documentation by using Good Documentation Practices (GDP) in support of cGEP and cGMP regulated activities.
  • Draft and Execute C&Q protocols (FAT/SAT/ IQ/OQ/IQ/OV/COM), assemble Turn Over Packages (TOP), assemble supporting documentation packages, and draft Final Summary Reports (FSR).
  • Assists is drafting or revising pre-requisite documentation such as User Requirement Specification (URS), System Impact Classification (SIC), and System Risk Assessments (SRA).
  • Collaborate with cross functional teams to support execution of C&Q tasks.
  • Works closely with Validation and Quality Assurance to ensure C&Q deliverables meet the Quality requirements.
  • High school diploma with additional technical courses (Scientific, Engineering or Quality fields) preferred, or recent engineering graduates looking for entry level positions.
  • 0-2 years of experience in at least one of the following areas: Commissioning, startup, or qualification of equipment. 
  • 2-5 years of prior experience as manufacturing operator, maintenance technician in a chemical, food, medical device or pharmaceutical company may be considered in lieu of C&Q experience. 
  • Good written and oral communications skills, including technical writing
  • Good problem-solving and trouble-shooting skills
  • Good interpersonal and organizational skills
  • Computer skills including Microsoft Word and Microsoft Excel
  • Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is helpful
  • Experience using statistical tools is a plus to analyze data captured during qualification/ validation studies
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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Amber Greene

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