Manufacturing Sr. Readiness Specialist

4 days ago

Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Position OverviewThe Manufacturing Readiness Specialist leads the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us.
We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's 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.Job DescriptionEssential Functions:Responsible for leading and participating in the following activities within the Manufacturing Support Services function:Materials/ConsumablesLead the effort in drafting and finalizing 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.Lead the effort in preparing material specifications to enable purchasing and release of materials/consumables for use in GMP manufacture.Lead or coordinate purchase order creation for client owned/client delivered materials.Deliver inputs and outputs necessary for SAP recipe creation.Work with Manufacturing and Supply Chain to follow-up on material ordering and receipt status for GMP manufacturing.Generate PO for consumables as applicable.Provide training and guidance to junior staff.Serve as subject matter expert on readiness activities.DocumentsCreate standard work for manufacturing readiness, execution, and disposition activities for new customer programs.Author batch records.Generate SOP's 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.Provide training and guidance to junior staff.Serve as subject matter expert on readiness activities.Equipment and Readiness CoordinationLead or coordinate room/equipment changeover.Ensure all equipment is in the room prior to 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., post-use sanitization buffers, AKTA calibration buffers and materials, etc.Provide PIP support.Originate and track manufacturing work orders, as necessary.Perform all other duties as assigned.Provide training and guidance to junior staff.Serve as subject matter expert on readiness activities.Continuous Learning and ImprovementLead or participate 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 self-discipline and attention to detail.Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift hours 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 distinct 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 hand-eye 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:Bachelor's Degree and six (6) years of experience, with three (3) in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORAssociate degree and eight (8) years of experience, with four (4) in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORHigh School Diploma or GED and ten (10) years of experience, with five (5) in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations.Preferred Qualifications:Previous leadership experience.Experience with both Upstream and Downstream cell culture processes.Experience with material control and testing requirements.Experience with SAP, MasterControl, Track wise, CIMBA, and BMRAM.EEO InformationFujifilm is committed to 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 InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (****** or (979) 431-3500).
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