Compliance/Deviation Investigator

1 week ago

New York, United States Trinity Consultants - Advent Engineering Life Science Solutions Full time

REMOTE


ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.


ADVENT's 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 group 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.


This is an outstanding opportunity to join our growing team


Compliance/Deviation Investigator

Essential Duties and Responsibilities include, but are not limited to the following:

• Writing, leading, and managing detailed investigations.

• Performance of Fact Finding, Assessment and Determination of Root Cause (RCA), generation of CAPAs, and coordination and management of cross-functional teams.

• A high level of aptitude for cGMP biopharmaceutical manufacturing processes (upstream/downstream), including process knowledge of UF/DF Systems, Chromatography, Bioreactors, Seed Train, Disposable Technologies (SUMs, SUBs), Clean-in-Place (CIP), and Steam-in-Place (SIP).

• A high level of aptitude for metrology, maintenance systems, preventative maintenance, HVAC, WFI, Clean Steam (CS), Compressed Air Pharmaceutical.

• Responsible for generating and tracking performance metrics.

• Maintains knowledge of current good manufacturing practices cGXPs.


Knowledge, skills, and abilities:

• 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. in addition to experience working within shared work environments.

• Strong interpersonal, written and oral communication skills.

• Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.

• Shows resiliency and flexibility in the face of challenges and adversarial situations and tight deadlines.

• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.

Education and Experience:

• A minimum of BS/BA in scientific or engineering discipline with 3+ years of related experience in investigations and cGMP manufacturing operations (clinical and/or commercial drug products).

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