Regulatory Compliance Investigator

4 weeks ago

Toronto, Canada Trinity Consultants - Advent Engineering Full time

This position is intended for Canadian Citizens willing to work onsite.

On-Site Regulatory Compliance Investigator

Trinity Consultants - Advent Engineering is a consulting firm specializing in the pharmaceutical and biotechnology sectors. With a presence across North America and Asia, our organization engages in a wide range of global pharmaceutical and biotechnology facility design, process engineering, and quality system initiatives.

Our services encompass process engineering, automation solutions, project management, facility/system design, startup and commissioning, validation, and compliance consulting 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 various processes, systems, and facilities. A blend of robust technical skills, automation engineering expertise, and technical documentation capabilities is essential.

This role presents an exceptional opportunity to contribute to our expanding team.

Key Responsibilities:


• Conducting, leading, and managing comprehensive investigations.


• Performing fact-finding, assessment, and root cause analysis (RCA), developing corrective and preventive actions (CAPAs), and coordinating cross-functional teams.


• Demonstrating a strong understanding of cGMP biopharmaceutical manufacturing processes, including upstream and downstream processes, as well as knowledge of UF/DF systems, chromatography, bioreactors, seed trains, disposable technologies, clean-in-place (CIP), and steam-in-place (SIP).


• Exhibiting a high level of proficiency in metrology, maintenance systems, preventative maintenance, HVAC, WFI, clean steam, and compressed air pharmaceutical systems.


• Responsible for the generation and monitoring of performance metrics.


• Keeping abreast of current good manufacturing practices (cGXPs).

Qualifications:


• Comprehensive knowledge of drug product manufacturing from formulation to final packaging.


• Fundamental understanding of regulatory compliance, including cGMP, FDA regulations, and familiarity with ICH guidelines and EU regulations.


• Proficient in Microsoft Excel, PowerPoint, Visio, Word, SharePoint, and experience in collaborative work environments.


• Excellent interpersonal, written, and verbal communication skills.


• Demonstrates confidence, high emotional intelligence, and strong communication skills for team updates.


• Displays resilience and adaptability in challenging situations and tight deadlines.


• Listens to team members and stakeholders, fostering a productive team environment toward shared objectives.

Education and Experience:


• A minimum of a BS/BA in a scientific or engineering discipline with at least 3 years of relevant experience in investigations and cGMP manufacturing operations.

Applications will be accepted until the role is filled. Only selected applicants will be contacted for interviews.

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