Manufacturing associate jobs in Durham, NC - 192 jobs

Randstad Enterprises is a partner for talent that creates opportunity! In this Biomanufacturing Associate position, you will have an opportunity to work in a well-respected Biotechnology company AND have the support you need with a career coach guiding you towards success :) Also learning tons within the cGMP manufacturing space while doing a job that will make a difference to others! Why work a contract position with Randstad? Career Coach Benefits available (Medical/Dental/Eye) Robust on the job training and eLearning's This requisition represents multiple open positions on the manufacturing teams. Opportunities working the Night or Day Shift: 24-hour facility working 12-hour shifts: 6-6 working a 2-2-3 shift with differential pay nights and weekends Contract: 6 months with potential for an extension Needed for success: Self-starter with AMAZING PROFESSIONALISM AND ETHIC High adaptability to changing needs and demands with willingness to tackle whatever comes your way Positive and motivated attitude Mechanical aptitude (putting together equipment) Experience with process automation systems Able to do some heavy lifting (25+ lbs.) Job Responsibilities: cGMP, Aseptic, and GDP is a MUST Manufacturing activities according to standard operating procedures, solution lot records and batch production records Troubleshooting processes and mechanics Able to work with both automated and un-automated processes Calculations as it relates to biomanufacturing Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.) Upstream / Cell Culture: Mammalian cell culture & harvest Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L Performing thaws and splits utilizing Aseptic technique Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance Education: Preferred - 2 years AA in the Sciences with 6+ months related experience Must Have - Biowork and a Highschool diploma with 1+ years' experience

GMP Manufacturing/Laboratory Technician Onsite in Chapel Hill, NC Contract for 1 year GMP Manufacturing Technician The Good Manufacturing Practices (GMP) facility focused on expansion and manipulation of human cells for clinical phase 1 applications, specifically including applications involving chimeric antigen receptor (CAR) T cells. The Client Facility also manufactures Master Cell Banks (MCBs) used in the production of clinical grade gamma retrovirus vector for use in CAR T clinical trials. Activities include cell culture work within an ISO 7 clean room environment. Working aseptically in a Biological Safety cabinet. Follow SOPs and execute cell counting, making manufacturing decisions as needed to support patient products being manufactured. Know when to ask questions and look for support in manufacturing when questions should arise. Helping to maintain inventory stock in clean rooms and release space. Supporting variety of other manufacturing duties as they come up as needed. Will be required to lead or support projects for validations of manufacturing systems.

This position is on a 2-2-3 shift, 6p-6a. The Manufacturing Associate I/II - Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II - Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time' (RFT). Downstream is responsi ble for the execution of purification activities for early and late-phase Cell Culture programs within a GMP environment. The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, various other filtration techniques utilizing single use technologies. Various analytical tools (SoloVPE, pH/Conductivity meters) and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, scales) are used on a daily basis. Following task execution, the Manufacturing Associate I/II will review the executed production records (SR's, ERP, and BR's) to ensure GxP compliance. Position Responsibilities Purification of cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, purification processing using various chromatography, filtration, and viral reduction techniques up through bulk fill of drug product/intermediate. Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution. Ensure all materials/items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR) Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. Participate and be accountable for room 5S. Utilize and perform maintenance on equipment per applicable SOP's. Position Requirements High school diploma. Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations. Ability to follow written instructions. Excellent written and verbal communication skills. Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Energetic, motivated and dynamic individual. Must have high attention to detail. Ability to work a 12-hour schedule to include weekends, nights and Holidays. Preferred Qualifications Associates or Bachelor's degree in a related scientific or engineering discipline Biowork certification. Experience in single-use platform technology. Experience in a CDMO. Salary: $24.00-31.25/hour, plus a shift differential Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, Mirror Polishing, media blasting, filing, cleaning, and packaging. Essential Duties and Responsibilities: Duties and responsibilities Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications and Experience: High school diploma or GED required Associates or post-secondary education preferred Experience in the use Rotary tools, Die Grinders, is required Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred Tools and Equipment Position may involve the use of: Basic hand tools Rotary tools Media blasting cabinet Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection Position may involve handling of or exposure to metallic powders and other powered materials, mill coolant, tapping fluid, polymeric resins, cleaning solutions, inert gases, and acids. Physical Activities Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Working conditions may also include working in a clean room environment. Clean room environment will require wearing PPE - Gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control• Performs in-process testing (pH, conductivity, visual inspection)• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)• Maintains training to perform all required manufacturing activities• Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area• Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)• Assists the lead with tasks in manufacturing activities• Assists with the coordination of daily shift activities• This role may require shift work (weekend and potential for nights)• Performs other duties as assigned Basic Requirements * High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment• Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR• Bachelor's Degree, preferably Life Sciences or Engineering OR• Equivalent Military training or experience Preferred Requirements * Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection) * BioWorks or BTEC Capstone cGMP coursework preferred WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Be exposed to an environment that may necessitate respiratory protection * May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program * Will work in environment operating a motor vehicle or Powered Industrial Truck * Ability to discern audible cues * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers * Ability to operate machinery and/or power tools * Ability to conduct work that includes moving objects up to 33 pounds * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions * Will work in heights greater than 4 feet To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm 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 Information If 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 (FDBN_****************).

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do During the project phase Participate and support testing activities, such as FAT, PQ etc. as well as other related activities Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions Contribute to the preparation for operational readiness related to bulk drug product manufacturing Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support Travel up to 0-25% (international or domestic) may be required during the project phase In operations Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control Perform operations of the Drug product filling line Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) Own the establishment of processes and trainings to become a trainer for coworkers Maintain compliance of GMP documents and ensure own training level is complaint and maintained Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed This role requires shift work (weekend and potential for nights) Perform other duties as assigned Basic Requirements High School Diploma or GED 6+ years of direct experience in a manufacturing environment Preferred Requirements Associate's Degree + 4 years of direct experience in a cGMP manufacturing environment OR BA/BS + 2 years of direct experience in a cGMP manufacturing environment Equivalent Military training or experience Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing) Understanding of manufacturing run cadence and order of shift activities Knowledge of cGMP, safety and operational procedures A high degree of knowledge and expertise of the operation of specific production equipment WORKING CONDITIONS & PHYSICAL REQUIREMENTS Be exposed to an environment that may necessitate respiratory protection Be exposed to noisy environments Have a normal range of vision Climb ladders and stairs of various heights Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required May be required to lift up to 50 pounds on occasion To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm 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 Information If 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 (FDBN_****************).

Job Title: Manufacturing and Production Positions Job Type: Temporary to Full Time About Us: iBoost Talent is a leading staffing agency dedicated to a talent first approach, with years of industry experience. iBoost supports all service models, contingent, temp-to-hire, direct hire, and our proprietary managed services offering Our mission is to simplify the job search process and provide thoughtful solutions for both job seekers and employers. If you're ready to explore your next opportunity, apply today. Job Summary: Join our dynamic team as a Manufacturing Worker in Raleigh, NC. We are actively seeking motivated individuals with experience in various manufacturing roles, including assemblers, machine operators, production technicians, and quality control inspectors. This is an excellent opportunity to advance your career in the manufacturing industry with a leading company known for its commitment to quality and innovation. Key Responsibilities: Assemblers: Assemble components and products according to specifications and quality standards. Material Handlers: Move, load, and unload materials and products within the facility. Production Workers: Assist in the production process, ensuring efficiency and adherence to safety protocols. Forklift Operators: Operate forklifts and other material handling equipment to transport goods safely. Maintenance Technicians: Perform routine maintenance and repairs on machinery and equipment. Inventory Specialists: Monitor inventory levels, conduct counts, and ensure accurate recordkeeping. Machine Operators: Set up and operate machinery, ensuring quality standards and production rates are met. Quality Control Specialists: Inspect products and processes to ensure compliance with company and industry standards. CNC Operators: Operate CNC machines, following blueprints and technical drawings to create precise components. Machinists: Use tools and machinery to fabricate, modify, and repair parts and components. Qualifications: High school diploma or equivalent; technical training or certifications in relevant fields are a plus. Previous experience in manufacturing or production roles is preferred but not required; we welcome entry level candidates. Strong attention to detail and commitment to quality. Ability to work in a fast-paced environment and adapt to changing demands. Good communication skills and ability to work effectively in a team setting. Willingness to work flexible hours, including overtime as needed. Physical Requirements: Ability to lift [insert weight] pounds and stand for extended periods. Comfortable working in a manufacturing environment with exposure to noise, dust, and varying temperatures. What We Offer: Competitive pay. Health, dental, vision, and life insurance Opportunities for career advancement and skill development. EOE Thank you for your interest in iBoost Talent, we are proud to be an Equal Employment Opportunity Employer and participate in the E-Verify eligibility confirmation program.

Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Manufacturing (Day Shift) Live What you will do Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation assistance will be provided for these positions. With general direction, the Associate will support all floor operations in accordance with cGMP practices. Responsibilities will include... Compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance Assure proper gowning and aseptic techniques are always followed Process/Equipment/Facilities: Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions Perform documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities Maintain an organized, clean, and workable space Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications. Basic Qualifications: High School/GED + 2 years manufacturing and/or other regulated environment experience Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience Or Bachelor's Degree Preferred Qualifications: Completion of NC BioWork Certificate Program Experience in a regulated industry such as biotechnology or pharmaceutical Basic understanding and process experience in a cGMP manufacturing facility Excellent verbal and written communication Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible No relocation assistance will be provided for these positions Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 75,618.00 USD - 89,473.00 USD

************************************************* xmlns="********************************* The PCX Manufacturing Technician supports a variety of engineering and production activities including equipment set-up and validation of new equipment, development and implementation of process improvements, process troubleshooting, monitoring of process data, assistance with creating and updating of process documentation, prototype execution, and assistance with preparation for new product introductions. The Manufacturing Technician is responsible for completing all assigned work according to specifications in a high quality and safe manner. The Manufacturing Technician assists and advises other employees in the assembly and production of switchgear and other electrical systems. Manufacturing Technicians understand and participate in the PCX quality program, to include KANBAN inspection scheduling and in-process inspections, and are knowledgeable in the project process flow, working with the engineering department during project planning and execution. They are required to follow the instructions of the electrical supervisor and suggest improvements. Specific Position Requirements: Must follow PCX safety guidelines and requirements Able to read, interpret, and understand blue prints and electrical schematics Develop detailed understanding of processes and equipment to identify and solve process issues through troubleshooting, data analysis, and collaboration with stakeholders across the Engineering, Operations, Maintenance, and Quality teams Support process validation projects by aiding with set-ups, engineering studies, and related testing Provide administrative support such as developing and updating manufacturing documentation and tracking and reporting on process performance Support execution of projects including DMAIC, LEAN, 5S, cost reduction and process improvement initiatives Install and connect power supply wiring, control wiring, cables, conduit, and electrical apparatus for machines and equipment following diagrams, schematics, or blueprints Inspect jobs upon completion and ensure areas are clean Ensure that equipment is in safe operating condition Follow established safety procedures and techniques to perform job duties Must verify conformance of work to specifications Must exhibit quality workmanship that adheres to engineering and customer specifications Adheres to PCX Quality Management System and ISO9001 standards Works in a timely, efficient manner to meet all daily performance objectives Maintains tools and equipment in proper working condition Must be able to read and understand posted bulletins, regulations, rule books, manufacturer manuals, and work instructions Must be able to work in a team environment which requires cooperating with others, offering help when needed, and maintaining positive work relationships Complete Time Reporting Sheets Report inventory use as required Able to lift 50# consistently Ability to work 10 hours per day and weekends as required Must have a valid Driver's License Background check and drug-screen are required

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The person filling this position operates all equipment in two assigned Manufacturing areas. • He or she will also clean equipment and facilities, and provide documentation of all duties in accordance with Good Manufacturing Practices. • Incumbent will perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures. • The incumbent will be required to attend quality-training programs and orientations on an annual or as needed basis. • This individual will be required to become familiar with domestic and international regulatory requirements associated with manufacturing and biological processes. • Annual performance goals and objectives will be evaluated against specific quality performance requirements as defined by the Manufacturing Supervisor. • Mandatory commitment to report to management any potential or actual deviations from regulatory requirements. • Ongoing input regarding quality process improvements. • Master documentation procedures by following detailed written and verbal instructions in order to complete assigned tasks (follow area SOP s). • Demonstrate knowledge of procedures by performing tasks and duties and maintaining detailed records in a manner compliant with cGMPs. • Perform routine job duties, which may include vacuuming, mopping ceilings, walls and floors, emptying trashcans, etc. • Prepare production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens. • Clean and sterilize process equipment (tanks, fermentors) as needed. • Demonstrate and instruct proper gowning and aseptic processing procedures. • Work with individuals as a team. • Work various shifts and some weekends. • Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor. • Train new employees on production processes. • Perform lab work, such as: performing sample dilutions, pH, and conductivity readings. The following combinations of education and work experience are considered acceptable: • BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience • AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience • HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience • Or progression from Bio-processing Technician Level I. that includes additional internal development curriculum List certificates (if any) required. • Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements. • Must complete training and comply with applicable cGMP requirements. Minimum number of years of prior experience required to perform job duties. A minimum of four years pharmaceutical experience in biological manufacturing is preferred. List specific skills and minimum expertise (ie., typing speed (WPM), fully trained ability to learn, etc.) required to perform job duties • Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis. • Basic understanding of the metric system. • Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns. • Must possess mechanical ability to assemble and operate equipment. • Must pay attention to detail by following procedures and noting unusual conditions. • Must have written and oral communication to read procedures, write accurate observations and follow directions Additional Skills: • GMP experience required • Pharma experience highly preferred • Bioprocessing experience in a cGMP environment, knowledge of Clean and Steam in Place Systems, perform facility cleanings, collecting WFI and Clean Steam samples. • Experience with autoclave and industrial washers Qualifications • BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience • AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience • HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience • Or progression from Bio-processing Technician Level I. that includes additional internal development curriculum Additional Information Akriti Gupta Associate Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

This position operates on a night shift 2-2-3 schedule. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment. The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest). The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance. The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability. Position Responsibilities Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality, company policies, and current regulations Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures Document each task involving manufacturing records and logbooks following GDP at the time of execution Utilize and perform maintenance on equipment per applicable SOP Ensure all materials are issued and accounted for during the execution of a record Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities Participate and be accountable for workplace organization Position Requirements Manufacturing Associate II- Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations; or high school diploma and 4-6 years' experience, or equivalent Basic knowledge of upstream processing- cell culture or fermentation Experience in single-use platform technology is preferred *Please note: this is a night shift opportunity and will be eligible for a shift differential on top of listed salary* Salary Range: $24-$31.25/hour Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Additive Manufacturing Technicians will be responsible for the operation of 3D LBPF metal printers, including CAD model review, build preparation. Monday - Friday, 2:00 pm - 10:30 pm PRINCIPAL RESPONSIBLITIES Principal responsibilities for the position include the following. Other duties may be assigned as necessary. Full operation of 3d metal printers. Includes machine unload, setup, operation, maintenance and general upkeep and troubleshooting. CAD model review, build preparation and general software support for metal printers. Reviewing model drawings and processing requirements and creating device records. Aid in post-processing steps done on common shop equipment (micro-blasting, grinding wheel, deburring tools). Aid in testing of verification samples on hydraulic and electronic test frames. Support R&D engineers during testing of devices for other purposes. Follow all appropriate safety precautions, including usage of PPE and maintaining lab cleanliness. Visual inspection of manufactured goods as part of quality-controlled process. EDUCATION High school diploma or GED Some college education is preferred. Preference given to technical training and degree work. EXPERIENCE Strong attention to detail Ability to work in a regulated industry, including adherence to proper paperwork protocols and good quality practices. Ability to routinely lift 35 lbs during a shift Ability to be standing for 3+ hours during a shift Strong visualization skills TOOLS AND EQUIPMENT Position may involve the use of: Basic hand tools Direct Metal Printers Polymeric 3D Printers Media Blasting Cabinet Testing Frames Cleaning and Inspection Equipment Respirator and fire-retardant PPE MATERIALS HANDLING / EXPOSURE Position will involve handling of ultra-fine, medical grade, metallic powder. May involve handling of other raw materials and waste material applicable to the manufacture of medical devices. SUPERVISORY RESPONSIBILITIES Position does not have supervisory responsibilities. PHYSICAL ACTIVITIES Position requires the ability to intermittently lift and carry up to 35 pounds and to operate while wearing a full-face respirator, protective clothing, eye protection, and/or hearing protection. A respirator fit test will be required prior to working with a respirator. Position may require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder. WORKING CONDITIONS Working conditions include standard office and laboratory conditions as well as conditions of a machine shop. Machine shop conditions may include noise, dust, and elevated temperatures. restor3d is an equal opportunity employer

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation. Job Description What You'll Do During the project phase * Participate and support testing activities, such as FAT, PQ etc. as well as other related activities * Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions * Contribute to the preparation for operational readiness related to bulk drug product manufacturing * Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support * Travel up to 0-25% (international or domestic) may be required during the project phase In operations * Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control * Perform operations of the Drug product filling line * Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) * Own the establishment of processes and trainings to become a trainer for coworkers * Maintain compliance of GMP documents and ensure own training level is complaint and maintained * Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed * This role requires shift work (weekend and potential for nights) * Perform other duties as assigned Basic Requirements * High School Diploma or GED * 6+ years of direct experience in a manufacturing environment Preferred Requirements * Associate's Degree + 4 years of direct experience in a cGMP manufacturing environment OR * BA/BS + 2 years of direct experience in a cGMP manufacturing environment * Equivalent Military training or experience * Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing) * Understanding of manufacturing run cadence and order of shift activities * Knowledge of cGMP, safety and operational procedures * A high degree of knowledge and expertise of the operation of specific production equipment WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Be exposed to an environment that may necessitate respiratory protection * Be exposed to noisy environments * Have a normal range of vision * Climb ladders and stairs of various heights * Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours * Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required * May be required to lift up to 50 pounds on occasion To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately 6:00AM-6:00PM). These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation. *** Please note that this posting represents multiple openings within our manufacturing organization *** Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do During the project phase, you may: Participate and support testing activities, such as: FAT, PQ etc. Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions) Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support Once we are operational, you may: Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control Perform operations of functional area Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) Own or establish processes and trainings to become a trainer for coworkers Maintain compliance of GMP documents and ensure your own training level is compliant and maintained Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed This role requires shift work (weekend and potential for nights) Perform other duties as assigned Basic Requirements Manufacturing Associate 2 High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR Associate's Degree in Life Sciences with 0 years of related experience OR Equivalent Military training/experience Manufacturing Associate 3 High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR BA/BS in Life Sciences with 0 years of experience OR Equivalent Military training/experience Manufacturing Associate 4 High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR Associate degree with 4 years' experience in Life Sciences Manufacturing OR BA/BS with 2 years of experience in Life Sciences Manufacturing OR Equivalent Military training/experience Manufacturing Associate 5 High School Diploma or GED with 8 years' experience in a Life Sciences Manufacturing environment OR Associate Degree with 6 years' experience in a Life Sciences Manufacturing environment OR BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing OR Equivalent Military Experience WORKING CONDITIONS & PHYSICAL REQUIREMENTS Be exposed to an environment that may necessitate respiratory protection. Be exposed to noisy environments. Have a normal range of vision Climb ladders and stairs of various heights. Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours. Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required. May be required to lift up to 50 pounds on occasion. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm 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 Information If 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 (FDBN_****************).

**HOW MIGHT YOU DEFY IMAGINATION?** You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Associate Manufacturing** **(Day Shift)** **Live** **What you will do** Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation assistance will be provided for these positions. With general direction, the Associate will support all floor operations in accordance with cGMP practices. **Responsibilities will include...** **Compliance:** + Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance + Assure proper gowning and aseptic techniques are always followed **Process/Equipment/Facilities:** + Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area + Run and monitor critical process tasks per assigned procedures + Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) + Complete washroom activities: cleaning equipment, small to large scale, used in production activities + Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions + Perform documentation for assigned functions (i.e., equipment logs, EBRs) + Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities + Maintain an organized, clean, and workable space **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications. **Basic Qualifications:** + High School/GED + 2 years manufacturing and/or other regulated environment experience Or + Associate's Degree + 6 months manufacturing and/or other regulated environment experience Or + Bachelor's Degree **Preferred Qualifications:** + Completion of NC BioWork Certificate Program + Experience in a regulated industry such as biotechnology or pharmaceutical + Basic understanding and process experience in a cGMP manufacturing facility + Excellent verbal and written communication + Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems + An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: + Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans and bi-annual company-wide shutdowns + Flexible work models, including remote work arrangements, where possible + No relocation assistance will be provided for these positions **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** **\#AmgenNorthCarolina** Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Manufacturing Associate I will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance. The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment The position will work on a rotating 2 - 2 -3 work schedule. This is a night shift position. The normal work hours are 7:00 pm - 7:00 am. Primary Responsibilities: Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations. Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures. Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution. Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR). Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities. Maintain and uphold 5S standards in the manufacturing environment. Operate and perform maintenance on equipment per applicable Standard Operating Procedures. Minimum Requirements: Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience. Energetic, motivated and dynamic individual. Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Language Ability: Fluent in English language both reading and writing. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. Physical Demands Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors. Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software Equipment Use Knowledge of and experience using equipment - (Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, other lab, production, and office equipment.) Work Conditions: The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. Work Hours: 12 Hour Shift / 7PM-7AM / 2-2-3 The job requires working 12-hour shifts which may include working overnight. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging. Essential Duties and Responsibilities: Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications: High school diploma or GED required Associates or post-secondary education preferred Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred TOOLS AND EQUIPMENT Basic hand tools Rotary tools Polymeric 3D printers Media blasting cabinet Furnace or ovens Materials testing frames Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection MATERIALS HANDLING / EXPOSURE Position may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids. Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Work environment may also include a controlled environment requiring the technician don PPE such as gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT (Approximately 6:00PM-6:00AM). These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation. * Please note that this posting represents multiple openings within our manufacturing organization * Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do During the project phase, you may: * Participate and support testing activities, such as: FAT, PQ etc. * Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions) * Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing * Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support Once we are operational, you may: * Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control * Perform operations of functional area * Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) * Own or establish processes and trainings to become a trainer for coworkers * Maintain compliance of GMP documents and ensure your own training level is compliant and maintained * Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed * This role requires shift work (weekend and potential for nights) * Perform other duties as assigned Basic Requirements * Manufacturing Associate 2 * High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR * Associate's Degree in Life Sciences with 0 years of related experience OR * Equivalent Military training/experience * Manufacturing Associate 3 * High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR * Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR * BA/BS in Life Sciences with 0 years of experience OR * Equivalent Military training/experience * Manufacturing Associate 4 * High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR * Associate degree with 4 years' experience in Life Sciences Manufacturing OR * BA/BS with 2 years of experience in Life Sciences Manufacturing OR * Equivalent Military training/experience * Manufacturing Associate 5 * High School Diploma or GED with 8 years' experience in a Life Sciences Manufacturing environment OR * Associate Degree with 6 years' experience in a Life Sciences Manufacturing environment OR * BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing OR * Equivalent Military Experience WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Be exposed to an environment that may necessitate respiratory protection. * Be exposed to noisy environments. * Have a normal range of vision * Climb ladders and stairs of various heights. * Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours. * Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required. * May be required to lift up to 50 pounds on occasion. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm 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 Information If 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 (FDBN_****************).

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do • Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control • Performs in-process testing (pH, conductivity, visual inspection) • Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) • Maintains training to perform all required manufacturing activities • Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area • Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection) • Assists the lead with tasks in manufacturing activities • Assists with the coordination of daily shift activities • This role may require shift work (weekend and potential for nights) • Performs other duties as assigned Basic Requirements • High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment • Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR • Bachelor's Degree, preferably Life Sciences or Engineering OR • Equivalent Military training or experience Preferred Requirements • Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection) • BioWorks or BTEC Capstone cGMP coursework preferred WORKING CONDITIONS & PHYSICAL REQUIREMENTS Be exposed to an environment that may necessitate respiratory protection May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program Will work in environment operating a motor vehicle or Powered Industrial Truck Ability to discern audible cues Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color Ability to ascend or descend ladders, scaffolding, ramps, etc Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers Ability to operate machinery and/or power tools Ability to conduct work that includes moving objects up to 33 pounds Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions Will work in heights greater than 4 feet To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm 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 Information If 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 (FDBN_****************).