Senior Investigator Drug Product
Senior Investigator Drug Product
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Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations identify root cause and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors internal auditors and senior leadership as needed regarding the findings of investigations. Additionally this role mentors and provides guidance to junior investigators throughout the investigation process.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
WhatYoullDo
Project Phase (Through Mid2025
Supports the transfer of the deviation management process from the Denmark site
Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness as needed
Performs any in operations duties listed below that are required prior to routine operations
Operations (Starting Mid2025
Performs major and complex manufacturing investigations to support DPFG
Applies systematic casual analysis methods to identify root and contributing causes for assigned investigations
Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
Communicates investigation progress to impacted areas including DPFG management
Collaborates with key stakeholders during the analysis of situations and data the root cause analysis (RCA) process and the development of CAPAs to successfully and thoroughly complete manufacturing investigations
Manages investigation workload tracks milestones throughout the process and ensures ontime closure of assigned investigations
Assigns deviations for the DPFG Deviations Management team
Mentors junior investigators on the investigation process including the development of the investigation team use of appropriate RCA tools and CAPA development
Leads and participates in process improvement initiatives for the investigation process
Reviews and creates metric reports for senior leadership
Delivers effective informative and engaging presentations regarding investigations metrics etc. to senior leadership or other stakeholders as needed
Engages with regulatory inspectors and internal auditors as needed
Collaborates crossfunctionally and across sites to maintain alignment on process and system improvements due to investigative findings and risk analysis
Other duties as assigned
Basic Requirements
High School Diploma/GED with 12 years related experience; OR
Associates degree in Life Sciences or Engineering with 10 years of direct experience (e.g. investigations); OR
Bachelors degree in Life Sciences or Engineering with 8 years of direct experience (e.g. investigations); OR
Equivalent Military experience
Experience in quality or manufacturing operations
Prior experience leading complex manufacturing investigations
Preferred Requirements
Root Cause Analysis (RCA) training
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
- Ability to discern audible cues
- Ability to stand for prolonged periods of time Up to 30 Minutes
- Ability to sit for prolonged periods of time Up to 60 Minutes
- Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumessubmittedby search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will bedeemedthe sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who wassubmittedoutside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Required Experience:
Senior IC
Employment Type
Unclear
