What are the responsibilities and job description for the Compliance/Deviation Investigator position at Trinity Consultants - Advent Engineering?
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 :
Education and Experience :
Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted. No phone calls please.
