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Investigation Specialist
2 months ago
Onsite Investigation Specialist
Trinity Consultants - Advent Engineering is a premier engineering and consulting firm dedicated to delivering specialized services to the pharmaceutical and biotechnology sectors. With a strong presence across North America and Asia, our organization is engaged in a wide array of global projects encompassing facility design, process engineering, and quality system enhancements.
Our offerings include comprehensive services such as process and automation engineering, project management, facility/system design, commissioning, validation, and compliance consulting tailored for leading biotechnology and pharmaceutical manufacturers.
The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of diverse processes, systems, and facilities. A blend of robust technical skills, automation engineering expertise, and proficient technical writing is essential for this role.
Key Responsibilities:
- Conducting, leading, and managing thorough investigations.
- Performing fact-finding missions, assessments, and root cause analysis (RCA), along with generating corrective and preventive actions (CAPAs) and coordinating cross-functional teams.
- Demonstrating a high level of understanding of cGMP biopharmaceutical manufacturing processes, including upstream and downstream operations, with knowledge of UF/DF systems, chromatography, bioreactors, seed trains, and disposable technologies.
- Exhibiting expertise in metrology, maintenance systems, preventative maintenance, HVAC, WFI, clean steam, and compressed air pharmaceutical systems.
- Responsible for the creation and monitoring of performance metrics.
- Staying updated on current good manufacturing practices (cGXPs).
Qualifications:
- Proficient understanding of drug product manufacturing from formulation to final packaging.
- Basic knowledge of regulatory compliance, including cGMP, FDA regulations, and familiarity with ICH guidelines and EU regulations.
- Skilled in using software tools such as Excel, PowerPoint, Visio, Word, and SharePoint, with experience in collaborative work environments.
- Strong interpersonal, written, and verbal communication abilities.
- Demonstrates confidence, high emotional intelligence, and effective communication skills for team updates.
- Exhibits resilience and adaptability in challenging situations and tight deadlines.
- Understands and addresses the needs of team members and stakeholders while fostering a collaborative team environment towards shared goals.
Education and Experience:
- A minimum of a BS/BA in a scientific or engineering discipline, accompanied by over three years of relevant experience in investigations and cGMP manufacturing operations.
