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Investigation Specialist
2 months ago
Onsite Investigation Specialist
Trinity Consultants - Advent Engineering is a prominent engineering and consulting firm dedicated to serving 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 related to pharmaceutical and biotechnology facility design, process engineering, and quality system initiatives.
Our offerings encompass process engineering, automation solutions, 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 diverse processes, systems, and facilities. A blend of robust technical skills, automation engineering expertise, and technical documentation proficiency is essential.
Key Responsibilities:
- Conducting, leading, and managing comprehensive investigations.
- Performing fact-finding missions, assessments, and root cause analysis (RCA), along with generating corrective and preventive actions (CAPAs) and coordinating cross-functional teams.
- Possessing a deep understanding of cGMP biopharmaceutical manufacturing processes (both upstream and downstream), including knowledge of UF/DF systems, chromatography, bioreactors, seed train processes, disposable technologies, clean-in-place (CIP), and steam-in-place (SIP) methodologies.
- Exhibiting expertise in metrology, maintenance systems, preventative maintenance, HVAC, water for injection (WFI), clean steam (CS), and compressed air pharmaceutical systems.
- Responsible for the creation and monitoring of performance metrics.
- Staying informed about current good manufacturing practices (cGXPs).
Qualifications:
- Understanding of drug product manufacturing processes from formulation to final packaging.
- Familiarity with regulatory compliance, including cGMP, FDA regulations, and awareness of ICH guidelines and EU regulations.
- Proficient in Microsoft Excel, PowerPoint, Visio, Word, SharePoint, and experienced in collaborative work environments.
- Strong interpersonal, written, and verbal communication skills.
- Demonstrates confidence, high emotional intelligence, and effective communication skills for team updates.
- Exhibits resilience and adaptability in challenging situations and tight deadlines.
- Actively listens to team members and stakeholders to foster a productive team environment towards shared objectives.
Education and Experience:
- A minimum of a Bachelor’s degree in a scientific or engineering discipline with over three years of relevant experience in investigations and cGMP manufacturing operations.
**Please note, we are not able to work with any 3rd party vendors or C2C.**
