Investigation Specialist

1 week ago

Chicago, Illinois, United States Trinity Consultants - Advent Engineering Full time

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 various regions, our organization engages in a comprehensive range of global 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 robust technical aptitude, automation engineering expertise, and proficient technical writing skills are essential for this role.

Key Responsibilities:

  • Conducting, leading, and managing comprehensive 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 processes, and familiarity with systems such as UF/DF, chromatography, bioreactors, and disposable technologies.
  • Demonstrating a high level of knowledge in metrology, maintenance systems, preventive maintenance, HVAC, and pharmaceutical-grade utilities.
  • Accountable for generating and monitoring performance metrics.
  • Maintaining up-to-date knowledge of 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 and EU guidelines.
  • Skilled in using software tools such as Excel, PowerPoint, Visio, Word, and SharePoint, with experience in collaborative work environments.
  • Excellent interpersonal, written, and verbal communication skills.
  • Exhibiting confidence, emotional intelligence, and strong communication skills for effective team interactions.
  • Demonstrating resilience and adaptability in challenging situations and tight deadlines.
  • Listening to and understanding the needs of team members and stakeholders while fostering a collaborative team environment.

Education and Experience:

  • A minimum of a Bachelor’s degree in a scientific or engineering discipline, accompanied by at least 3 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.**

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