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Investigation Specialist
2 months ago
Onsite Investigation Specialist
Trinity Consultants - Advent Engineering is a prominent engineering and consulting organization specializing in the pharmaceutical and biotechnology sectors. With a significant presence across North America and Asia, our firm engages in a wide array of global projects related to pharmaceutical and biotechnology facility design, process engineering, and quality systems.
Our comprehensive services encompass process engineering, automation engineering, project management, facility/system design, startup and commissioning, as well as validation and compliance consulting for esteemed biotechnology and pharmaceutical manufacturing enterprises.
The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of various processes, systems, and facilities. A blend of robust technical skills, automation engineering expertise, and technical writing capabilities are essential for this role.
Key Responsibilities:
- Conducting, leading, and managing thorough investigations.
- Performing fact-finding missions, assessments, and root cause analysis (RCA), generating corrective and preventive actions (CAPAs), and coordinating cross-functional teams.
- Possessing a strong understanding of cGMP biopharmaceutical manufacturing processes, including upstream and downstream operations, as well as familiarity with UF/DF systems, chromatography, bioreactors, seed trains, and disposable technologies.
- Demonstrating expertise in metrology, maintenance systems, preventative maintenance, HVAC, WFI, clean steam, and compressed air pharmaceutical systems.
- Accountable for developing and monitoring performance metrics.
- Staying informed about current good manufacturing practices (cGXPs).
Qualifications:
- Proficient knowledge of drug product manufacturing from formulation to final packaging.
- Basic understanding of regulatory compliance, including cGMP, FDA regulations, and familiarity with ICH guidelines and EU regulations.
- Skilled in using Excel, PowerPoint, Visio, Word, SharePoint, and experienced in collaborative work environments.
- Excellent interpersonal, written, and verbal communication skills.
- Demonstrates confidence, high emotional intelligence, and strong communication skills for team updates.
- Exhibits resilience and adaptability in challenging situations and tight deadlines.
- Listens to team members and stakeholders, fostering a productive team environment towards shared objectives.
Education and Experience:
- A minimum of a BS/BA in a scientific or engineering discipline with over three years of relevant experience in investigations and cGMP manufacturing operations (clinical and/or commercial drug products).
**Please note, we are not able to work with any 3rd party vendors or C2C.**
