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Commissioning & Qualification Technician
Birmingham, AL 35211 US
Job Description
- 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
Meet Your Recruiter
Amber Greene
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