Manufacturing Readiness Coordinator II
Manufacturing Readiness Coordinator II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
Summary: The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure rightfirsttime on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Company Overview
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 FDB and help create 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 FUJIFILM Diosynth Biotechnologies call Genki.
College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.
Job Description
Essential Functions:
Responsible for participating in the following activities within the Manufacturing Support Services function:
Materials/Consumables
- Draft and finalize process consumables list for new client programs
- Work with Supply Chain Process Development Manufacturing Operations Quality Control and Quality Assurance to identify materials and consumables appropriate for GMP manufacture.
- Familiar with preparing material specifications to enable purchasing and release of materials/consumables for use in GMP manufacture.
- Coordinate purchase order creation for client owned/client delivered materials
- Deliver inputs and outputs necessary for SAP recipe creation
- Works with Manufacturing and Supply Chain to followup on material ordering and receipt status for GMP manufacturing.
- Generate PO for consumables as applicable
Documents
- Create standard work for manufacturing readiness and disposition activities for new customer programs
- Author batch records
- Generate SOPs and applicable forms for new equipment and route them in document control system
- Generate WR for changes / service as needed.
- Generate route and close Change Controls for equipment as required
- Familiar with drafting Batch Production Records from Process Specs update per client review and route for approval
- Review Unicorn Methods and DeltaV recipes with Process Engineer
- Review product sample plans
- Generate Intermediate and Final product labels and client approval forms as necessary
- Review Process Specification
- Create tier 2 placards for each new client program.
- Review campaign summary report
- Support Failure Modes and Effects Analysis (FMEA) risk assessments.
- Support Potential Problem Analysis (PPA) events
Equipment and Readiness Coordination
- Coordinate room/equipment changeover
- Ensure all equipment is in the room prior cleaning and room release.
- Coordinate room release
- Coordinate with facilities any service or Preventive Maintenance/Corrective Maintenance that needs to be performed to the room or system/equipment in the room.
- Identify availability and schedule equipment usage as necessary.
- Review Unicorn methods
- Assist Process Engineers with room layouts
- Induct new/updated equipment into Blue Mountain asset management system
- Ensure equipment location data is current in Blue Mountain
- Generate work requests for changes/service as required
- Assist Manufacturing Techs to identify / request / retrieve needs prior to process e.g. Postuse sanitization buffers AKTA calibration buffers and materials etc.
- Provide PIP support
- Originates and tracks manufacturing work orders as necessary.
- Performs all other duties as assigned.
Continuous Learning and Improvement
- Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention
Required Skills & Abilities:
- Good oral and written communication skills interpersonal and organizational skills.
- Practical understanding of equipment used in bioprocessing (downstream and/or upstream)
- Proficient with Microsoft Office applications.
- Good selfdiscipline and attention to detail.
- Must have flexible work hours must be willing to work outside of normallyscheduled hours as necessary; including opportunities for alternative shifthours and weekends as required.
- Experience working in clean room environments.
- Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to:
- Experience prolonged standing some bending stooping pushing pulling reaching above shoulders and stretching.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
Qualifications:
- Masters Degree and two 2 years of experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
- Bachelors Degree and four 4 years of experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
- Associate degree and six 6 years of experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
- High School Diploma or GED and eight 8 years experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations
- All above requirements must include at least two 2 years of GLP or GMP experience
Preferred Qualifications:
- Experience with both Upstream and Downstream cell culture processes
- Experience with material control and testing requirements
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 or.
Required Experience:
IC
Employment Type
Unclear
