FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies | Manufacturing Readiness Coordinator II | col
FUJIFILM Diosynth Biotechnologies, College Station, Texas, United States,
Summary:
The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Essential Functions:Responsible for participating in the following activities within the Manufacturing Support Services function:Materials/ConsumablesDraft and finalize process consumables list for new client programsWork 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 materialsDeliver inputs and outputs necessary for SAP recipe creationWorks with Manufacturing and Supply Chain to follow-up on material ordering and receipt status for GMP manufacturing.Generate PO for consumables as applicableDocumentsCreate standard work for manufacturing readiness, execution, and disposition activities for new customer programsAuthor batch recordsGenerate SOP's and applicable forms for new equipment and route them in document control systemGenerate WR for changes / service as needed.Generate, route and close Change Controls for equipment as requiredFamiliar with drafting Batch Production Records from Process Specs, update per client review and route for approvalReview Unicorn Methods and DeltaV recipes with Process EngineerReview product sample plansGenerate Intermediate and Final product labels and client approval forms as necessaryReview Process SpecificationCreate tier 2 placards for each new client program.Review campaign summary reportSupport Failure Modes and Effects Analysis (FMEA) risk assessments.Support Potential Problem Analysis (PPA) eventsEquipment and Readiness CoordinationCoordinate room/equipment changeoverEnsure all equipment is in the room prior cleaning and room release.Coordinate room releaseCoordinate 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 methodsAssist Process Engineers with room layoutsInduct new/updated equipment into Blue Mountain asset management systemEnsure equipment location data is current in Blue MountainGenerate work requests for changes/service as requiredAssist Manufacturing Techs to identify / request / retrieve needs prior to process e.g. Post-use sanitization buffers, AKTA calibration buffers and materials, etc.Provide PIP supportOriginates and tracks manufacturing work orders as necessary.Performs all other duties as assigned.Continuous Learning and ImprovementParticipates in team projects relating to Operational Excellence such as Problem Analysis and PreventionRequired 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 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 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:Master's Degree and two (2) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORBachelor’s Degree and four (4) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORAssociate degree and six (6) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORHigh School Diploma or GED and eight (8) years’ experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operationsAll above requirements must include at least two (2) years’ of GLP or GMP experiencePreferred Qualifications:Experience with both Upstream and Downstream cell culture processesExperience with material control and testing requirementsWe are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.
The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Essential Functions:Responsible for participating in the following activities within the Manufacturing Support Services function:Materials/ConsumablesDraft and finalize process consumables list for new client programsWork 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 materialsDeliver inputs and outputs necessary for SAP recipe creationWorks with Manufacturing and Supply Chain to follow-up on material ordering and receipt status for GMP manufacturing.Generate PO for consumables as applicableDocumentsCreate standard work for manufacturing readiness, execution, and disposition activities for new customer programsAuthor batch recordsGenerate SOP's and applicable forms for new equipment and route them in document control systemGenerate WR for changes / service as needed.Generate, route and close Change Controls for equipment as requiredFamiliar with drafting Batch Production Records from Process Specs, update per client review and route for approvalReview Unicorn Methods and DeltaV recipes with Process EngineerReview product sample plansGenerate Intermediate and Final product labels and client approval forms as necessaryReview Process SpecificationCreate tier 2 placards for each new client program.Review campaign summary reportSupport Failure Modes and Effects Analysis (FMEA) risk assessments.Support Potential Problem Analysis (PPA) eventsEquipment and Readiness CoordinationCoordinate room/equipment changeoverEnsure all equipment is in the room prior cleaning and room release.Coordinate room releaseCoordinate 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 methodsAssist Process Engineers with room layoutsInduct new/updated equipment into Blue Mountain asset management systemEnsure equipment location data is current in Blue MountainGenerate work requests for changes/service as requiredAssist Manufacturing Techs to identify / request / retrieve needs prior to process e.g. Post-use sanitization buffers, AKTA calibration buffers and materials, etc.Provide PIP supportOriginates and tracks manufacturing work orders as necessary.Performs all other duties as assigned.Continuous Learning and ImprovementParticipates in team projects relating to Operational Excellence such as Problem Analysis and PreventionRequired 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 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 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:Master's Degree and two (2) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORBachelor’s Degree and four (4) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORAssociate degree and six (6) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; ORHigh School Diploma or GED and eight (8) years’ experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operationsAll above requirements must include at least two (2) years’ of GLP or GMP experiencePreferred Qualifications:Experience with both Upstream and Downstream cell culture processesExperience with material control and testing requirementsWe are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.