Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.
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
Project Phase (Through Mid-2026)
* Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed• Performs "in operations" duties listed below as required prior to routine operations
Operations (Starting Mid-2026)
* Completes major internal manufacturing investigations to support DSM• Supports senior investigators with complex investigations, as needed• Applies systematic casual analysis methods to identify root and contributing cases for assigned investigations• Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements• Communicates investigation process to impacted areas, including management, and tracks milestones throughout the investigations• Partners with key stakeholders during the development of CAPAs to support the investigation process• Manages investigation workload to ensure closure of investigations within required timeline• Supports senior investigators during assignment of workload for DSM Deviations Management team, as needed• Contributes to metric reports to prepare presentations for senior leadership• Delivers informative and engaging presentations regarding metrics and other relevant information to required stakeholders, as needed• Provides guidance to junior investigators regarding investigative techniques and best practices• Other duties, as assigned
Basic Requirements
* High School Diploma/GED with 9 years of related experience (e.g., investigations); OR• Associate's degree in Life Sciences or Engineering with 7 years of related experience (e.g., investigations); OR• Bachelor's degree in Life Sciences or Engineering with 5 years of related experience (e.g., investigations); OR• Equivalent Military experience• Experience in quality or manufacturing operations• Prior experience leading manufacturing investigations
Preferred Requirements
* Experience with systematic cause analysis methods (e.g., Event & Casual Factor Analysis, Logic Fault Tree, or similar techniques)
* Root Cause Analysis (RCA) training
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Will work in environment operating a motor vehicle or Powered Industrial Truck
* Ability to discern audible cues
* Ability to stand for prolonged periods of time
* Ability to sit for prolonged periods of time
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$97k-146k yearly est. Auto-Apply 60d+ ago
Looking for a job?
Let Zippia find it for you.
Manufacturing Associate 4, Drug Product Filling (2nd Shift - 3PM-11:30PM)
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
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.
$29k-35k yearly est. Auto-Apply 39d ago
Vaccine Key Customer Leader - Central CA
Merck 4.6
Remote or Raleigh, NC job
Under the guidance of the Director, Commercial Operations-Vaccines, the Vaccine Key Customer Leader (VKCL) is the primary Vaccine point of contact for our company with assigned large private and public sector customers within their designated market. The VKCL engages with C-/ D-suite customers in assigned accounts and collaborates with the extended company field team to ensure implementation and pull-through at the individual clinic/hospital/provider level.
**Responsibilities include and are not limited to the following:**
+ The VKCL will be accountable for the Vaccines business performance, business relationship and customer experience with assigned customers, coordinating appropriate company resources and personnel to meet the needs of the customer.
+ Actively develops, enhances and applies a deep understanding of assigned customers, the local market healthcare /vaccination ecosystem, and ensuing interplay and translates into potential business opportunities.
+ Demonstrates and applies in-depth knowledge of the vaccination landscape including: vaccination schedule, quality measures, reimbursement processes, key factors affecting uptake, local immunization registries, coalitions, school requirements.
+ Responsible for demonstrating strong collaboration and coordination with all company customer-facing roles. With all assigned accounts, the VKCL will be responsible for building a Vaccines account strategy focused on increasing appropriate use of our company's Vaccines and coordinating the account team execution consistent with the strategy and customer needs.
+ Identifies key vaccine decision-makers and influencers, understands their concerns and priorities, builds trusting relationships that differentiate our company.
+ Collaborates with internal and customer stakeholders to formulate approach and select/deploy solutions to meet customer needs.
+ Identifies strategic customers within region/geography that afford our company differentiated business opportunities and prioritizes their importance.
+ Stays abreast of competitor approaches and our company's customer contracting strategy; engages appropriate account team members (field and HQ) to capitalize on opportunities to grow/defend the Vaccine business.
**Education Requirements:**
+ Required: BA/BS
+ Preferred: MA/MS/MBA in Business, Marketing, Science, Healthcare or Public Health
**Required Experience:**
+ Minimum of five (5) years experience in Sales leadership, Key Account Management / Client Service Management, Marketing, and/or Strategy preferably in the Healthcare industry
+ Minimum of two (2) years experience working in Sales leadership or Strategic Account Management with key thought leaders or high influence customers in Public Health, Large Group Practices, Hospitals/Systems, or Managed Care Organizations
+ Ability to build and develop customer relationships, including the ability to influence senior levels of management and key thought leaders
+ Excellent interpersonal and communication skills, with ability to interact with individuals from a variety of cultures, and disciplines
+ Strong peer leadership and ability to collaborate with and coordinate activity among individuals in different reporting structures within the organization
+ Self-motivated with the ability to perform with a high level of independence
+ Innovative thinking and exceptional business acumen, analytical and problem-solving skills
+ Proficient in Microsoft Excel, PowerPoint, Word and Outlook
+ Valid Driver's License
+ Travel (25%) varies based on candidate's location within the geography.
**Preferred Experience:**
+ Minimum of two (2) years experience working in/with Vaccines; strong understanding of Vaccination (products, processes, marketplace)
+ Recent Local Market and Customer Knowledge
+ Experience in a strategic or management role in Public Health or Health System/Medical Group
+ Strong understanding of compliance-related concepts including the laws and regulations that govern Pharmaceutical/Vaccine Marketing and Sales activities
**Required Skills:**
Accountability, Accountability, Account Management, Business Opportunities, Client Management, Commercial Account Management, Consumer Relations, Contract Management, Customer Experience Management, Customer Management, Customer Needs Analysis, Customer Relationship Management (CRM), Data Analytics, Executive Management, Financial Acumen, Healthcare Trends, Identifying Sales Opportunities, Independent Thinking, Interpersonal Relationships, Key Account Planning, Lateral Leadership, Leadership, Managed Care Marketing, Market Research, Profit Planning {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$169,700.00 - $267,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/12/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R377859
$169.7k-267.2k yearly 24d ago
Senior Specialist 1, Quality Control Lab Support
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration.
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:
* Initiates and authors deviations, CAPA's, and change controls for the functional groups within QC
* Initiates and supports actions for implementation of solutions, process improvements and CAPAs
* Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation
* Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product updates for controlled GMP documents related to sample plans and specifications
* Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies
* Participates in cross-functional team meetings to gain exposure to QC's role in various business processes
* Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members
* Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation
* Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
* Provides recommendations to management on KPI's as needed to evaluate the changes made
* Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports Interacts with clients as needed to support change controls and deviations
* Documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks
* Identifies and escalates sample issues to appropriate parties
* Performs other duties, as assigned
Minimum Requirements:
* Bachelor's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
* Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
* 1- 3 years relevant experience, experience in a GMP environment
Preferred Requirements:
* Experience with KNEAT software
* Experience qualifying analytical instruments
Working & Physical Conditions:
* 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 up to 60 minutes.
* Ability to sit for prolonged periods of time up to 60 minutes.
* Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
* Ability to conduct work that includes moving objects up to 10 pounds.
* Will work in small and/or enclosed spaces.
* 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.
* #LI-Onsite
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_****************).
$113k-143k yearly est. Auto-Apply 1d ago
Manager, Supplier Quality
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Parkton, NC
The Manager, Supplier Quality and Material Control ensures supplied materials meet company standards through a combination of auditing suppliers' quality systems, inspecting, and analyzes quality data, and collaborative problem-solving with suppliers and internal teams to resolve issues while implementing continuous improvement initiatives. The Manager is responsible for the inspection and release of all Good Manufacturing Practice (GMP) consumables, raw materials, and labeling manufactured product, in addition to the release of manufacturing utilities, rooms, and equipment used in manufacturing processes and maintenance of the QA retention program. This role interacts with regulatory agencies during compliance inspections, manages supplier change notifications, deviations, corrective and preventive actions (CAPAs), and change controls while partnering with engineers, management and room owners. Additionally, the Manager provides leadership to quality specialists and ensures the team is position to successfully support a 24/7 manufacturing facility.
Company Overview
At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
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:
* Manages a team of quality specialists and determines priorities to ensure successful completion of projects and tasks
* Problem solves on supplier change notifications and deviations to determine effective solutions and root causes
* Coordinates the Vendor Change Notification Committee
* Approves all Raw Material and Consumable Item Specifications
* Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectiveness
* Serves as the QA point of contact for Warehouse, Planning, and QC Raw Material escalations
* Reviews and approves relevant Material Control, Warehouse, QC Raw Material, standard operating procedures (SOPs) and STMs
* Supports client and regulatory inspections and serves as the subject matter expert (SME) for deviations, CAPAs and change controls, as needed
* Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed
* Provides metric and key performance indicators (KPIs) updates to the QMR lead
* Provides Quality assessments for materials related deviations, lab investigation and change controls
* Administers company policies such as time off, shift work, and inclement weather that directly impact employees
* Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
* Coaches and guides direct reports to foster professional development
* Participates in the recruitment process and retention strategies to attract and retain talent, as needed
* Performs other duties, as assigned
Minimum Requirements:
* Master's degree in quality, business management or other related field with 5+ years of experience; or
* Bachelor's degree in quality, business management or other related field with 7+ years of experience; or
* 2-5 years of people management experience
* Prior experience working in a CDMO
* #LI-Onsite
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 (HR_*****************).
$118k-144k yearly est. Auto-Apply 60d ago
Engineer 3, Clean Utilities
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Clean Utilities Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.
Job Description
What You'll Do
* Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards•Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline•Prepares deviations and change control resolutions and closures•Performs reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site•Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings•Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)•Reviews and approves Preventative Maintenance templates for equipment within assigned discipline•Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues•Develops or provides supports in the development of User Requirement Specs (URSs), Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting procedures•Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers•Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems•Participates in audits with customer representatives and regulatory agencies, as needed•Performs simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshooting•Cross-trains within multiple disciplines to assist team with achieving deliverables•Collaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety)•Other duties, as assigned
Knowledge & Skills
* Effective communication, both written and verbal•Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations•Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)•Ability to analyze and troubleshoot simple to moderate system and component related issues•Ability to effectively present information to others•Willingness to provide feedback to others, including leaders
Required Skills
* Bachelor's Degree in Engineering with 5 years of experience with process utility related components and systems•Experience working in a GMP or other highly regulated environment
Preferred Skills
* Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systems
Working Conditions & Physical Requirements:
PHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection. X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X YesWill work in environment operating a motor vehicle or Powered Industrial Truck. X No YesAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. No X Yes 60 minutes Ability to sit for prolonged periods of time. No X Yes 240 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. No X YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes ENVIRONMENTAL CONDITIONSWill work in warm/cold environments. No X Yes 30-100 F RangeWill work in outdoor elements such as precipitation and wind. No X YesWill work in small and/or enclosed spaces. No X YesWill work in heights greater than 4 feet. No X Yes
$68k-106k yearly est. Auto-Apply 43d ago
Oncology Sales Representative - Mobile / Montgomery, AL
Merck 4.6
Remote or Raleigh, NC job
**Oncology Sales Representative / Specialist** Grow and accelerate your career with our Oncology Sales organization and join a team that's driven to make an impact on cancer patients! We take a customer-centric approach by leveraging emerging digital technologies and data analytics to better understand our customers' needs. Developing your career with us will allow you to join a group of passionate professionals, driven by purpose and determined to help save and improve lives.
Come join a driven, customer-focused, and collaborative team. As an Oncology Sales Representative, you will be a key member engaging with customers to address identified needs, educating key stakeholders about our oncology products, and actively working to achieve or exceed assigned sales goals within your territory.
+ This is a field-based sales position that is responsible for the **Mobile / Montgomery, AL** territory.
+ This territory includes **Montgomery, Mobile and Panama City, FL.**
+ Candidates must be willing to travel to visit with customers in-person and for national sales meetings/industry conferences.
+ Travel (%) and overnight requirements vary based on candidate's location.
**Key responsibilities include and may not be limited to:**
+ Working with the other team members in the territory, attain or exceed the assigned sales goals for the geography.
+ In collaboration with territory counterparts, ensure customers have a seamless experience with our Oncology team, meet with key stakeholders to understand practice structure, and business model, while building business relationships and trust to uncover and comprehend their needs.
+ In customer engagements, employ approved resources and messaging to communicate a compelling, patient-centered rationale for our Oncology products in their indicated uses.
+ Possess knowledge of the workings of the extended care team/multidisciplinary team, cancer staging, possible treatment options, pathways, and guidelines associated with different tumors/diseases, recognizing the impact of those options on patients.
+ Analyze and identify trends in a complex buying environment, including multiple channels of drug distribution (Oncology group purchasing organizations, wholesalers, and specialty pharmacies).
+ Review and evaluate patterns for products purchased and prescribed (outpatient vs in-patient infusion, as part of hospital or GPO contract, etc.)
+ Comprehend complex accounts and local market interdependencies to proactively develop and execute short- and long-term plans in collaboration with the local team and district manager (known as the Oncology Customer Team Leader).
+ Ask insightful questions to understand customer priorities and needs to support engaging, approved, and relevant messaging about the product portfolio.
+ Ensure a consistent customer experience across our Company's division and functional areas and share key learnings to support customer needs by effectively communicating and collaborating with the in-scope customer team: Customer Team Leader, Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and more.
**Qualifications:**
**Minimum Requirements:**
+ Bachelor's degree with at least 6 years of sales experience OR a minimum of high school diploma with at least 8 years of equivalent experience.
+ Equivalent experience can be professional sales experience, work experience in the healthcare/scientific field with oncology experience being strongly preferred (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience.
+ Valid driver's license and able to drive a vehicle.
+ Travel the amount of time the role requires, including overnight travel 10 - 15%.
+ Reside in or within a reasonable distance to the district.
**Preferred Experience and Skills:**
+ 2+ years of oncology field-based experience selling an oncology therapeutic to oncology customers.
+ Oncology field sales or clinical oncology experience.
+ Documented history of strong performance in a sales/marketing or oncology clinical role.
MSJR
oncosales
**Required Skills:**
Accountability, Accountability, Account Management, Adaptability, Biopharmaceutical Industry, Business Case Development, Business Model Development, Business Relationship Building, Business Relationship Management (BRM), Consumer Trend Analysis, Customer Engagement, Customer Relationship Management (CRM), Data Analysis, Interpersonal Relationships, Lead Generation, Market Analysis, Marketing, Medication Distribution, Oncology, Oncology Nursing, Oncology Sales, Order Processing, Product Knowledge, Revenue Generation, Sales Forecasting {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$139,600.00 - $219,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
75%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
01/17/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R374881
$45k-54k yearly est. 53d ago
Intern, MSAT Lab
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The internship role is to support basic and routine laboratory activities in MSAT lab at Fujifilm Biotechnologies in Holly Springs. This role provides ad-hoc support to laboratory scientists in the execution of experiments in support of large-scale manufacturing (Drug Substance Manufacturing - DSM) and tech transfers.
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Preparation of buffers for Downstream operations and media for Upstream cell culture operations
* Set-up of laboratory equipment (bioreactors, filtration units)
* Picking samples up from DSM (admittance to DSM requires that the intern does not have make-up or permanent visible jewelry)
* Sampling of bioreactors
* Raw material sourcing including ordering and inventory control
* Housekeeping in the lab (operating dishwasher, staging waste for collection, general lab clean up).
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$27k-36k yearly est. Auto-Apply 7d ago
Tech 3, Utility Maintenance
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
Utility Maintenance 3 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water.
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
* Plans and perform preventative maintenance and repairs on Utility related equipment• Assists with developing and implementing maintenance strategies and programs to optimize equipment and systems• Assists with developing and implementing preventative maintenance plans to minimize equipment downtime• Maintains accurate maintenance records and documentation• Participates in overseeing validation and qualification activities to ensure compliance with regulatory requirements• Evaluates and recommends new equipment for purchases and upgrades• Collaborates with other departments to identify and address cross-functional issues• Assists management with budget forecast for maintenance and capital projects• Manages vendor relationships and negotiates contracts for maintenance services and equipment purchases• Performs preventive maintenance and troubleshooting on clean and black utility systems• Performs lock out tag out (LOTO) to complete maintenance activities, as required• Leads root cause investigations• Follows standard operating procedures (SOPs) and protocols to ensure compliance with safety and Good Manufacturing Practices (cGMP) quality standards• Adheres to all safety requirements and follows safe work practices• Notifies management or Environmental Health & Safety (EHS) when unsafe conditions or hazards are found• Attends all required safety and health training• Mentors' and provides training to technicians• Assists and provides recommendations to management to develop and maintain maintenance budgets and schedules• Supports site operations and emergency work orders during off-hours, as needed• Performs spare parts assessments, as required• Performs other duties, as assigned
Knowledge & Skills
* Ability to train or mentor technicians• Strong analytical and problem-solving skills• Effective communication, both written and oral• Knowledge of GMP regulations• Knowledge of Lean Six Sigma or other continuous improvement methodologies• Ability to interpret technical drawings and schematics• Ability to drive and prioritize multiple tasks
* Must be able to support 24/7 manufacturing facility, including shift, on-call and weekends
Required Skills
* High School Diploma/GED• 4-6 years of maintenance experience• Experience using, troubleshooting, and repairing mechanical, electrical, or other relevant systems• Experience with Computerized Maintenance Management System (CMMS) or Enterprise Asset Management (EAM)
Preferred Skills
* Associate degree in mechanical, electrical, chemical engineering or a related field• Prior maintenance experience in a manufacturing or pharmaceutical environment• Experience with regulatory inspections and audits• Experience with validation and qualification activities• Experience with programmable logics control (PLCs), human machine interference (HMIs), or other automation systems
Working Conditions & Physical Requirements:
* 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.
* May be required to operate a pallet jack
* 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 - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 60 minutes
* Ability to conduct activities using repetitive motions that include writs, 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.
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_****************).
$29k-37k yearly est. Auto-Apply 60d+ ago
Intern, Finance
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
As a Finance Intern, you will benefit from a hands-on experience that will provide you an opportunity to gain in-depth knowledge of our organization and culture. You will gain exposure to different areas of financial applications and processes. As a valuable team member, you will be given the opportunity to apply your exceptional analytical and problem-solving skills to a wide variety of finance and accounting activities. You will manage a project from start to finish, and culminate your summer experience by presenting your results to leadership.
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Work closely to support the department in development and implementation of processes
* Conduct research, ask questions, gather, and analyze data
* Prepare and/or review documents, reports and/or presentations
* Work closely with supervisor to determine internship project and achieve project goals
* Final presentation of assigned project at the conclusion of the internship
* Search for opportunities for continuous improvement
* Interact with department, cross-functional groups, and senior leadership
* Attend social and professional networking events
* Analyze budgets against actuals and forecast
* Assist in process optimization efforts to achieve more effective and efficient processes
* Engage with a variety of stakeholders across the organization for improving financial processes
* Establish internal controls for mitigation of risk
* Participates in risk review and analysis processes, including assistance with reporting
* Ad hoc management reporting requests
* Prepare and analyze various financial data sets
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Business Focus OR• Currently enrolled in a Business Focused Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$51k-65k yearly est. Auto-Apply 7d ago
Intern, Health & Safety
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
Interested in making a difference in the world and influencing the long-term environmental impact of a $2 Billion-dollar mega pharmaceutical project striving to be THE most sustainable biopharmaceutical CDMO in the US? Fujifilm Diosynth Biotechnologies is offering a Health and Safety internship for college students majoring in Environmental, Health, Safety, Sustainability or Engineering. This position will reside within the EHS and Sustainability Department and report to the Head of EHS and Sustainability.
This unique opportunity will interface with industry leading professionals from both Fujifilm and our global engineering partners to provide direct support in the development and execution of safety initiatives across the areas of design, construction, start-up and operations. Specific focus areas will include use of predictive leading indicators to minimize risk of injury, 3D design reviews and development of operational programs.
You will gain real-world, hands-on experience with some of the top professionals in the world. You will be exposed to cutting edge technologies and a culture of caring. You will be given the freedom to explore innovative opportunities which have yet to be implemented in the US. This role requires out of the box thinking, development of concepts into viable solution and ability to present complex concepts to a diverse audience. Are you ready for the opportunity of your life that could kickstart your career?
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Work closely to support the department in development and implementation of processes
* Conduct research, ask questions, gather, and analyze data
* Prepare and/or review documents, reports and/or presentations
* Work closely with supervisor to determine internship project and achieve project goals
* Final presentation of assigned project at the conclusion of the internship
* Search for opportunities for continuous improvement
* Interact with department, cross-functional groups, and senior leadership
* Attend social and professional networking events
* Support of Black Belt project focused on use of predictive, leading indicators to minimize risk of serious injury
* Develop operational Health and Safety standard operating procedures including confined space, lockout\tagout, fall protection, etc
* Conduct field inspections and corrective action closure
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific Undergraduate or Master's degree Program with a Environmental, Health, Safety, or Sustainability focus• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$27k-33k yearly est. Auto-Apply 4d ago
Engineer 2, Material Science
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Engineer or Scientist 2, Material Science supports the design of new single-use consumables in conjunction with our manufacturing teams. This role assists the leachable and extractables program, that includes facilitation of testing based on products evaluated. This role also supports manufacturing investigations involving material science (e.g., raw material variability and concerns, consumable issues and particle sources). The role writes investigation reports and leachable and extractable reports.
Job Description
What You'll Do
* Supports the team with the introduction of new raw materials, and associated document requirements
* Assesses vendor change notifications, and provides input on raw materials related matters
* Supports change requests for introduction, modification, and discontinuation of raw materials
* Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
* Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
* Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
* Supports process sub-teams throughout the phases of technology transfer (TT)
* Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
* Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
* Supports generation of sampling plans for process validation reports (PVRs) and investigations
* Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
* Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost
* Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives
* Other duties, as assigned
Knowledge and Skills
* Builds connections with key contacts within the department and outside specialty
* Communicates effectively within the team
* Engages in important conversations with cross-functional team members
* Develops basic hypotheses for projects
* Possesses fundamental project management skills. Effectively communicates information to others
* Thinks critically and self-directed with minimal oversight
* Understands basic project management and quality systems (e.g., Change Control, document management system)
* Strong communication and teamwork skills
* Solid grasp of material investigation methods Stays informed about regulatory and quality requirements in manufacturing
* Knowledgeable of material investigation principles and techniques
Basic Requirements
* Bachelor's degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; OR
* Master's degree in Engineering, Life Science or Chemical Engineering with no relevant experience
* Experience working in a Good Manufacturing Practices (GMP) environment
Preferred Requirements
* Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting
* Experience supporting the following:o Writing portions of regulatory filings and regulatory auditso New product launches and validation of processo Global or multi-site validation programs
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues.
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.
$81k-103k yearly est. Auto-Apply 4d ago
Intern, QA Operations DSM
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The QA Intern is responsible to assist in the Quality oversight of Drug Substance Manufacturing and supporting areas, bridging from site project/startup phase to operational readiness. The QA Intern collaborates within the Drug Substance Quality Operations team as well as with other project teams on site with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Supports QA for specific tasks and deliverables within the assigned Quality area
* Participates in streamlining and standardizing day to day quality related risks
* Maintain detailed schedules via Smartsheet, electronic and physical dashboards, and PowerPoint presentations as applicable
* Prepare and coordinate optimization of deliverables with other cross-functional stakeholders and internal customers.
* Accomplish assigned intern project tasks on agreed timelines
* Design/maintain a communication strategy to provide schedule, task, and status updates to the impacted teams.
* Other duties as assigned
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$51k-64k yearly est. Auto-Apply 1d ago
Intern, Supply Chain Operations
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Intern (Supply Chain) supports the Warehouse, Raw Material Sampling, and Weigh & Dispense operations tasked with assisting with operational projects and new business processes including working with third party logistics providers (3PLs), visual management implementation, document management. As part of the Supply Chain team, the Intern gains firsthand experience with supporting incoming material receipt, material movement and identification, and collaborating between supply chain and other teams.
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Collaborates with experienced Supply Chain team members on identified project(s).
* Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship.
* Documents and updates operational procedures
* Provides suggestions to improve business processes for operational efficiencies
* Gowns into classified for visual management implementation and to gain process knowledge, as needed
* Assists with development of material pack guide for 3PL
* Assists with ensuring procedures and practices are accurate and are documented
* Performs other duties, as assigned
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific or Supply Chain Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$76k-95k yearly est. Auto-Apply 7d ago
Raw Material Sampler 3
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).
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
Project Phase:•Assists in the preparation for operational readiness including but not limited to creating and implementing new SOPs, development or transfer of warehouse business processes, testing and commissioning support with validation, and start-up activities with SAP ERP•Completes interim responsibilities (e.g., attending Integrated Working Team (IWT) meetings, owning IWT milestones, ordering supplies and owner equipment, supporting CQV activities) for operational readiness at the FDBN large scale greenfield site•Travels up to 25% (international or domestic) Operations:•Transfers materials into and out of Raw Material Sampling using powered or manual industrial trucks (PIT)•Performs Grade D gowning and material transfers•Performs sampling operations per material specifications•Interfaces with Warehouse, supervision, Supply Chain and QC•Identifies issues and suggests resolutions•Uses analytical and bench top scales in sampling booths•Interfaces with warehouse and supervision•Identifies issues operations, equipment, systems, procedures, and initiates corrective action for resolution•Executes cycle counting material in Raw Material Sampling•Identifies and maintains inventory levels for efficient sample throughput and scheduling•Troubleshoots inventory discrepancies•Trains lower-level associates on Raw Material Sampling operations•Leads department GEMBA and safety walks•Fills in for Lead Associate, as needed•Acts as the Subject Matter Expert (SME) for Raw Material Sampling operations, as defined by leadership•Leads departmental continuous improvement efforts, as directed•Other duties, as assigned
Knowledge, Skills
* Ability to use respiratory and required PPE for dispensing•Knowledge of GMP and good distribution practice (GDP)•Intermediate knowledge of SAP material transactions and reports•Intermediate knowledge of LIMS and sample management•Intermediate understanding of cold chain and hazardous material handling•Knowledge of ERP for ordering and receiving warehouse materials•Intermediate understanding of sampling specifications• Ability to work shift work or weekend hours to support 24/7 operations and/or required to fulfill on-call responsibilities, as needed
Basic Requirements
* High School Diploma or GED with 6 years related experience in a manufacturing environment; or•Associate's Degree in Life Sciences or similar area with 4 years of related experience in a manufacturing environment; or•Bachelor's Degree with 2 years related experience in a manufacturing environment or Military experience of equivalence•Experience with analytical and bench top scales
* Previous weigh and dispense or raw material sampling experience
Preferred Requirements
* Prior experience operating industrial trucks•Experience with ERPs and LIMS, SAP and Labware•Previous GMP experience in a QC or sampling role•Experience training other associates
* Bioworks or BTEC Capstone cGMP coursework
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Will work in environment which may necessitate respiratory protection
* Will work in environment operating a motor vehicle or Powered Industrial Truck
* 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 wrists, hands and/or fingers
* 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 outdoor elements such as precipitation and wind
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_****************).
$74k-104k yearly est. Auto-Apply 55d ago
Associate Specialist , Manufacturing Automation
Merck 4.6
Remote or Durham, NC job
The Manufacturing Automation Associate Specialist position shall support a GMP testing laboratory at a manufacturing facility for sterile vaccine products. Responsibilities include supporting computer system validation, implementing process control and data collection, and troubleshooting in compliance with SDLC, cGMP, safety, and environmental regulations. The Manufacturing Automation Associate Specialist must actively support, participate, and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups. This role supports a large spectrum of sophisticated automated systems within Laboratory Operations, providing multiple opportunities to learn new automation technologies and make a positive impact.
Primary activities include, but are not limited to:
Performs routine assignments in the entry level of a professional role
Learns and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations. Review automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.
Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of product and on time project execution and system delivery.
Provide technical guidance/support including authoring or review of system qualification documents, change control, Quality Notifications (QNs), and other key automation related processes
Participates in audits and training programs in the area of responsibility.
Participates in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through process improvement, future expansion, replacement, or upgrade.
Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
On-floor support of manufacturing/laboratory activities.
Education Minimum Requirement:
B.S., B.A., or greater preferably in Engineering, Science, or Information Technology
Preferred Experience and Skills:
Experience in PLCs, SCADA, laboratory equipment, and/or PI.
Required Skills:
Accountability, Audit Management, Business Process Improvements, Collection Processes, Communication, Corrective Action Management, Data Collection Methods, Data Management, Environmental Health And Safety, Environmental Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Automation, Leadership, Manufacturing, Problem Management, Quality Management, Real-Time Programming, SCADA Control Systems, Software Development Life Cycle (SDLC), System Validation, Technical Leadership
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$71,900.00 - $113,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
01/19/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
$71.9k-113.2k yearly Auto-Apply 2d ago
Intern, Program Management
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Program Management intern will have the opportunity to work with the Program Management team and other functions to further develop our ways of working and leveraging the good practices from our sister site in Denmark as we transition from startup to operations.
Within Program Management, we are building the processes and tools that will support planning and delivery of customer programs from the point of contract signature through program closure. The program management department works to ensure first class customer service, aligning our contracted commitment to clients with our company vision/mission.
Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Development of Program Management processes for transitioning Programs from Tech Transfer to Commercial phase and routine manufacture
* Development of metrics and dashboards to support status and updates on commercial program delivery, drug product program delivery, handoff/transition of customer relationship from commercial team to Program Mangement
* Build framework to enhance communication and partnership across Program Management organization with Denmark site
* Performs other duties as assigned
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Science or Business focus OR• Currently enrolled in an Business or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$33k-40k yearly est. Auto-Apply 7d ago
Sr Analyst 1, QC Microbiology
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.
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
About This Role
* Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
* Leads sample collection and manages sample logistics for testing
* Supports testing for all qualification and study directed testing
* Supports investigation of routine OOS assays and events
* Conducts qualification and validation protocols
* Leads sterility testing
* Reviews intermediate lab testing results
* Troubleshoots complex assays
* Writes and assists with document preparation and review
* Manages project timelines
* Assists management with training and on-boarding of new staff as needed
* Embraces LEAN lab and six sigma principles and applies them to laboratory processes
* Champions projects and project management as assigned
* Performs other duties, as assigned
Minimum Qualifications
* Bachelor's with 2+ years of relevant Microbiology experience OR
* Master's with 0 years of experience • Experience with aseptic production & support
* 1-3 years in a GMP environment • Advanced understanding of GMP, GLP, GDP requirements
* Advanced knowledge in Microbiology theory
* Advanced knowledge of Microbiology testing and laboratory experience
* LIMS experience
* Experience with document control including reviewing and editing technical documents
* LEAN lab and Six Sigma training and/or certification
* Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
* Intermediate LIMS software training
* Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)
Preferred Qualifications
* Master's with 1+ years of experience
* 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
* Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
* Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
* Advanced LIMS / Trackwise software training
* Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
PHYSICAL REQUIREMENTS PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
WORKING ENVIRONMENT PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. No X Yes
Will work in heights greater than 4 feet. No X Yes
* ----
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_****************.
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_****************).
$103k-124k yearly est. Auto-Apply 15d ago
Intern: DPFG MSAT Process Engineer
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Drug Product and Finished Goods (DPFG) MSAT Intern will help setup the framework and systems of manufacturing process development and bioprocess data at FDBN. Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
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
Under the direct supervision, support and guidance of the manager:
* Collaborates with experienced engineers on identified project(s). Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship.• Builds up understanding of drug product and finished goods processes via daily process monitoring, in process control trending and data analysis • Assists in the optimization of equipment and manufacturing processes • Supports process issues and deviation investigations • Supports the system and logistics for MSAT samples (for process comparability, stability studies and investigation) • Ensures that all work is accurate, precise, properly documented, and compliant with SOPs and FDA cGMP guidelines• Assists MSAT process engineers/experts in supporting drug product and finished goods manufacturing operations, as applicable• Performs other duties, as assigned
Basic Requirements
* Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Rising Junior or above and enrolled in an Engineering or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Requirements
* Prior experience in Pharma/Biotech/Chemical Industry is preferred• Prior hands-on technical experience (in a laboratory or manufacturing environment)
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time - up to 60 minutes
* Ability to sit for prolonged periods of time - up to 240 minutes
* Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
* Ability to conduct work that includes moving objects up to 10 pounds
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All 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_****************).
$35k-45k yearly est. Auto-Apply 22d ago
Supervisor, Manufacturing Support
Fujifilm Diosynth Biotechnologies 4.0
Fujifilm Diosynth Biotechnologies job in Holly Springs, NC
The Supervisor, Manufacturing Support is responsible for leading the material, training and production scheduling teams within manufacturing support and their associated activities to ensure compliant and reliable production.
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
* Provides oversight and leads operational readiness projects including but not limited to leading the creation or transfer, from existing large-scale facility, manufacturing support team business processes to ensure good manufacturing practice (GMP) operational readiness• Leads and builds the process support team through project phase activities• Administers company policies such as time off, shift work, and inclement weather that directly impact employees • Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)• Other duties, as assigned
In operations
* Manages and develops direct reports from support manufacturing team • Oversees and coordinates the tasks of providing materials, training, and production schedule support to manufacturing• Administers company policies such as time off, shift work, and inclement weather that directly impact employees • Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)• Oversees the coordination of manufacturing activities (e.g., campaign materials, Kanban, vendor management inventory support, training and curriculum, detailed batch schedules, short flow investigations, and alert and action limits)• Manages manufacturing change controls and corrective and preventive actions (CAPAs)• Ensures continuous improvement, drives escalation and mitigates manufacturing issues• Supports and acts as a secondary lead for regulatory inspection and audits• Coaches and guides direct reports to foster professional development• Participates in the recruitment process and retention strategies to attract and retain talent, as needed• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution• Other duties, as assigned
Basic Requirements
* High School diploma/GED with 6 years related experience; OR• Bachelor's Degree in Life Science, Engineering, or related field with 2 years of related experience; OR• Master's Degree in Life Science, Engineering, or related field with no prior experience• Experience directly supporting manufacturing• Experience with regulatory inspections, investigations and change management
Preferred Requirements
* Experience in pharmaceutical or biological manufacturing operations• Experience leading others in a pharmaceutical or biological manufacturing facility• Experience working in a changing environment within a project driven organization
* Lean certification or similar certifications
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
* Ability to stand for prolonged periods of time
* Ability to sit for prolonged periods of time
* Ability to operate machinery and/or power tools
* Ability to conduct work that includes moving objects up to 10 pounds
* Will work in warm/cold environments
* Will work in outdoor elements such as precipitation and wind
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_****************).
$95k-116k yearly est. Auto-Apply 41d ago
Learn more about FUJIFILM Diosynth Biotechnologies jobs
Zippia gives an in-depth look into the details of FUJIFILM Diosynth Biotechnologies, including salaries, political affiliations, employee data, and more, in order to inform job seekers about FUJIFILM Diosynth Biotechnologies. The employee data is based on information from people who have self-reported their past or current employments at FUJIFILM Diosynth Biotechnologies. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by FUJIFILM Diosynth Biotechnologies. The data presented on this page does not represent the view of FUJIFILM Diosynth Biotechnologies and its employees or that of Zippia.
FUJIFILM Diosynth Biotechnologies may also be known as or be related to FUJIFILM Diosynth Biotechnologies, Fujifilm Diosynth Biotechnologies and Fujifilm Diosynth Biotechnologies U.S.A., Inc.