What are the responsibilities and job description for the CWI/Process Piping QA 3rd Party Inspector (Life Sciences/Biopharmaceutical) position at AM Technical Solutions, Inc?
CWI/Process QA 3rd Party Inspector (Life Sciences/Biopharmaceutical)
Responsible for conducting independent inspections, verification, and documentation of equipment, systems, and facilities in biopharmaceutical manufacturing environments to ensure compliance with cGMP regulations, client specifications, and industry standards.
Key Responsibilities:
- Perform detailed inspections of critical process equipment, clean utilities, and facility infrastructure.
- Review engineering documentation, drawings, and specifications.
- Verify installation qualification (IQ) activities.
- Witness factory acceptance tests (FAT) and site acceptance tests (SAT).
- Execute inspection protocols and document findings.
- Review vendor documentation for compliance.
- Generate detailed inspection reports and non-conformance reports.
- Participate in project meetings and timeline coordination.
- Provide technical guidance to clients and contractors.
Required Qualifications:
- Minimum 5 years' experience in Non-Destructive Testing on Process Piping systems.
- Strong knowledge of cGMP requirements and FDA regulations.
- Understanding of aseptic processing and clean room operations.
- Familiarity with process equipment and clean utilities.
- Experience with documentation review and technical writing.
- Strong analytical and problem-solving skills.
Preferred Qualifications:
- Experience with commissioning and qualification activities.
- Knowledge of ASME BPE standards.
- Experience with clean utilities (Pure Steam, WFI, Clean Steam).
- Familiarity with equipment vendor documentation requirements.
- Prior experience in project management.
Technical Knowledge:
- Clean room classifications and monitoring..
- Process equipment (bioreactors, filtration, chromatography)
- Clean utilities and critical systems.
- Material flow and personnel flow concepts.
- Sterilization and sanitization processes.
- Quality management systems.
- Risk assessment methodologies.
Soft Skills:
- Strong written and verbal communication.
- Attention to detail.
- Project coordination abilities.
- Time management skills.
- Ability to work independently.
- Strong interpersonal skills.
This position typically reports to a Senior Inspector or Project Manager and works closely with clients, contractors, and other project stakeholders.