What are the responsibilities and job description for the CWI/Process Piping QA 3rd Party Inspector (Hygienic - Pharmaceutical) 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.
Also have additional potential projects across the US depending on availability / interest in travel.
Key Responsibilities :
Perform detailed inspections of critical process equipment, clean utilities, and facility infrastructure.
Review engineering documentation, drawings, and specifications.
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 (Good Manufacturing Practices) 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. Relevant documents may include items pertaining to : material test reports, weld inspection logs, pressure tests, passivation, Class IV elastomers, slope, pipe, components, and instrument labeling as well as cleaning, flush, and blowdown.
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.
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