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Sirius Staffing
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Commissioning and Qualification
Job Description
Sirius Staffing is seeking a Qualification/Validation Specialist for a contract role in Birmingham, AL/ Please contact Sirius today for more information.
Schedule:
Onsite M-F 8am-5pm
Rate:
$50-55hr.
We are seeking a skilled Validation professional to support aseptic pharmaceutical manufacturing processes and equipment. This role requires strong hands-on experience in validation activities, a thorough understanding of regulatory expectations for sterile drug manufacturing, and proficiency with Kaye validation systems. The ideal candidate will have experience supporting commissioning, qualification, and validation (CQV) efforts within cGMP environments and will work cross-functionally to ensure reliable, compliant operations.
Key Responsibilities
Validation & Qualification
- Develop URS, SIC, and SRA documentation for new and existing aseptic equipment and facilities.
- Develop and execute Commissioning (COM), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Ensure all validation documentation meets internal Quality standards and regulatory requirements.
- Perform validation activities in at least two of the following areas:
- Cleaning Verification / Validation
- Autoclave / Steam Sterilization
- VHP Sterilization / Decontamination
- Aseptic Process Simulations (Media Fills)
- Dry Heat Depyrogenation
Equipment Qualification Experience (preferred):
- Homogenizers
- Pump skids
- SIP & CIP skids
- Temperature control units
- Tanks
- Requalification of CTUs
Computer System Validation (CSV)
- Develop and implement validation plans for computerized systems in alignment with FDA, EU, and internal policies.
- Conduct risk assessments focused on system functionality and data integrity.
- Create and maintain documentation (system classification, overviews, test scripts, reports).
- Execute CSV protocols to verify intended system performance.
Cross-Functional Collaboration
- Work independently and within multidisciplinary teams to meet project timelines.
- Communicate observations, results, and recommendations clearly at all organizational levels.
- Support continuous improvement of validation procedures, tools, and compliance strategies.
Required Qualifications
- Bachelor’s degree in engineering or a scientific discipline (other degrees with strong relevant experience considered).
- Minimum 3–5 years of experience in validation/qualification of aseptic pharmaceutical equipment, processes, or systems.
- Proficient hands-on use of Kaye Validator AVS and ValProbe Systems.
- Strong understanding of FDA/EU regulatory expectations, GAMP guidance, and cGMP requirements.
- Experience working within aseptic pharmaceutical manufacturing environments.
- Strong problem-solving, documentation, and organizational skills.
- Effective written and verbal communication skills.
- Proficiency with Word, Excel, PowerPoint, and similar applications.
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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About Birmingham, AL
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