Compliance Investigator
4 weeks ago
ADVENT Engineering is a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. With a strong presence in the US, Canada, and Singapore, our company is involved in various aspects of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
Our services include process engineering, automation engineering, project engineering, facility/system design, start-up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a team of engineers involved in the design, automation, commissioning, and start-up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills, and technical writing are the desired skill set.
Key Responsibilities:
- Conduct detailed investigations and lead cross-functional teams.
- Perform fact-finding, assessment, and determination of root cause (RCA), generation of CAPAs, and coordination of cross-functional teams.
- Develop a high level of aptitude for cGMP biopharmaceutical manufacturing processes, including process knowledge of UF/DF Systems, Chromatography, Bioreactors, Seed Train, Disposable Technologies, Clean-in-Place (CIP), and Steam-in-Place (SIP).
- Develop a high level of aptitude for metrology, maintenance systems, preventative maintenance, HVAC, WFI, Clean Steam (CS), Compressed Air Pharmaceutical.
- Generate and track performance metrics.
- Maintain knowledge of current good manufacturing practices cGXPs.
Requirements:
- Bachelor's degree in a scientific or engineering discipline.
- At least 3 years of related experience in investigations and cGMP manufacturing operations (clinical and/or commercial drug products).
- Strong technical aptitude, automation engineering skills, and technical writing.
- Knowledge of drug product manufacturing from formulation through the final package.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, Sharepoint, etc.
- Strong interpersonal, written, and oral communication skills.
Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted.
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