Manufacturing Associate II - Media Preparation (Nights)
Manufacturing associate job in Parkton, NC
About This Role
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.
Shift Details: This role follows a 2-2-3 calendar rotation on nights (5:45 PM - 6 AM ET)
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them.
Our teams are organized by the steps in the biomanufacturing process that they operate in; including - Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).
Upstream / Cell Culture:
Mammalian cell culture & harvest:
Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L
Performing thaws and splits utilizing Aseptic technique
Downstream / Purification:
Column Chromatography
Viral Filtration
Ultra-Filtration
Bulk Dispensing of the drug substance
What You'll Do
Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation or qualification protocols in accordance with cGMP and Standard Operating Procedures (SOPs).
Document all manufacturing work accurately, including cGMP data, deviations, equipment usage, and processing details. Create, revise, and maintain batch records, SLRs, equipment logbooks, and other key documentation.
Support in-process sampling and analysis, including routine measurements such as pH, conductivity, protein concentration, osmolality, and cell counts.
Maintain a clean, safe, and audit-ready workspace by following safety guidelines, good housekeeping practices, and compliance expectations.
Collaborate as a reliable team member, showing up with focus, accountability, and a willingness to support teammates and shared goals.
Participate in training and development, building your own capabilities while helping strengthen the skills and readiness of the team.
Who You Are
You're driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills
The following combination of academic and/or relevant experience may be considered:
Bachelor's degree from an accredited college or university
A BiWorks Certificate, associate's degree, or High School Diploma (or equivalent) and at minimum of 6 months of directly relevant experience
Experience in cGMP manufacturing, biotech, or pharmaceutical operations.
Ability to follow detailed procedures and uphold safety and compliance standards.
Familiarity with operating production equipment and maintaining manufacturing documentation.
Preferred Skills
Bachelor's degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university.
Strong communication skills and a team-oriented mindset.
Job Level: Entry Level
Additional Information
The base compensation range for this role is: $23.08-$29.81
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families
physical, financial, emotional,
and
social well-being
; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Auto-ApplyManufacturing Associate II - Media Preparation (Nights)
Manufacturing associate job in Parkton, NC
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on nights (5:45 PM - 6 AM ET) Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them.
Our teams are organized by the steps in the biomanufacturing process that they operate in; including - Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).
Upstream / Cell Culture:
* Mammalian cell culture & harvest:
* Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L
* Performing thaws and splits utilizing Aseptic technique
Downstream / Purification:
* Column Chromatography
* Viral Filtration
* Ultra-Filtration
* Bulk Dispensing of the drug substance
What You'll Do
* Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation or qualification protocols in accordance with cGMP and Standard Operating Procedures (SOPs).
* Document all manufacturing work accurately, including cGMP data, deviations, equipment usage, and processing details. Create, revise, and maintain batch records, SLRs, equipment logbooks, and other key documentation.
* Support in-process sampling and analysis, including routine measurements such as pH, conductivity, protein concentration, osmolality, and cell counts.
* Maintain a clean, safe, and audit-ready workspace by following safety guidelines, good housekeeping practices, and compliance expectations.
* Collaborate as a reliable team member, showing up with focus, accountability, and a willingness to support teammates and shared goals.
* Participate in training and development, building your own capabilities while helping strengthen the skills and readiness of the team.
Who You Are
You're driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills
* The following combination of academic and/or relevant experience may be considered:
* Bachelor's degree from an accredited college or university
* A BiWorks Certificate, associate's degree, or High School Diploma (or equivalent) and at minimum of 6 months of directly relevant experience
* Experience in cGMP manufacturing, biotech, or pharmaceutical operations.
* Ability to follow detailed procedures and uphold safety and compliance standards.
* Familiarity with operating production equipment and maintaining manufacturing documentation.
Preferred Skills
* Bachelor's degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university.
* Strong communication skills and a team-oriented mindset.
Job Level: Entry Level
Additional Information
The base compensation range for this role is: $23.08-$29.81
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
* Medical, Dental, Vision, & Life insurances
* Fitness & Wellness programs including a fitness reimbursement
* Short- and Long-Term Disability insurance
* A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
* Up to 12 company paid holidays + 3 paid days off for Personal Significance
* 80 hours of sick time per calendar year
* Paid Maternity and Parental Leave benefit
* 401(k) program participation with company matched contributions
* Employee stock purchase plan
* Tuition reimbursement of up to $10,000 per calendar year
* Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
API Manufacturing Associate I
Manufacturing associate job in Clayton, NC
About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
+ Leading pay and annual performance bonus for all positions
+ All employees enjoy generous paid time off including 14 paid holidays
+ Health Insurance, Dental Insurance, Vision Insurance - effective day one
+ Guaranteed 8% 401K contribution plus individual company match option
+ Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
+ Free access to Novo Nordisk-marketed pharmaceutical products
+ Tuition Assistance
+ Life & Disability Insurance
+ Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Operate API manufacturing equipment to achieve production goals.
Relationships
Reports to Shift Manager, Operations - API.
Essential Functions
+ Work in a safe & environmentally responsible manner
+ Follow instructions listed in GMP documentation & product quality
+ Review SOP's & other documents, as required
+ Real-time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
+ Manage individual training plan
+ Participate in qualification & validation activities as required
+ Setup, operate, monitor, & control highly automated processes & systems
+ Load & unload product from trucks, tankers & ISO containers, as required
+ Execute production schedule to achieve production goals
+ Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
+ Maintain clean room areas & perform environmental monitoring, as required
+ Other accountabilities, as assigned
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.
Qualifications
+ High school graduate or equivalent required
+ Associate's Degree or higher in Tech, Science, or Engineering preferred
+ BioWork or equivalent industrial, military or vocational training combined with experience preferred
+ Minimum two (2) years of manufacturing experience in FDA regulated environment preferred
+ Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred
+ Experience following SOPs to perform tasks & raising issues if errors are found preferred
+ Experience following established safety guidelines when performing tasks preferred
+ Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
+ Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
+ Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
+ Ensure compliance with corporate/local SOPs, regulations & ISO standards required
+ General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
+ Basic knowledge of biology/chemistry preferred
+ Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
+ Experience working with work permits/Lock Out Tag Out systems preferred
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Manufacturing Associate 3, Drug Product (2nd Shift - 3PM-11:30PM)
Manufacturing associate job in Holly Springs, NC
The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: ***************************************************
Job Description
What You'll Do
* Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control• Performs in-process testing (pH, conductivity, visual inspection)• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)• Maintains training to perform all required manufacturing activities• Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area• Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)• Assists the lead with tasks in manufacturing activities• Assists with the coordination of daily shift activities• This role may require shift work (weekend and potential for nights)• Performs other duties as assigned
Basic Requirements
* High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment• Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR• Bachelor's Degree, preferably Life Sciences or Engineering OR• Equivalent Military training or experience
Preferred Requirements
* Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection)
* BioWorks or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Be exposed to an environment that may necessitate respiratory protection
* May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
* Will work in environment operating a motor vehicle or Powered Industrial Truck
* Ability to discern audible cues
* Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
* Ability to ascend or descend ladders, scaffolding, ramps, etc
* Ability to stand for prolonged periods of time
* Ability to sit for prolonged periods of time
* Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers
* Ability to operate machinery and/or power tools
* Ability to conduct work that includes moving objects up to 33 pounds
* Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions
* Will work in heights greater than 4 feet
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
Auto-ApplyManufacturing Associate - Biologics (Multiple Openings)
Manufacturing associate job in Holly Springs, NC
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams.
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts (either days or nights) on a 2-2-3 calendar rotation.
*** Please note that this posting represents multiple openings within our manufacturing organization ***
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: ***************************************************
Job Description
What You'll Do
During the project phase, you may:
Participate and support testing activities, such as: FAT, PQ etc.
Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)
Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing
Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Once we are operational, you may:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control
Perform operations of functional area
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own or establish processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure your own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Basic Requirements
Manufacturing Associate 2
High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR
Associate's Degree with 0 years of related experience OR
Equivalent Military training/experience
Manufacturing
Associate 3
High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR
Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR
BA/BS with 0 years of experience OR
Equivalent Military training/experience
Manufacturing Associate 4
High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR
Associate degree with 4 years' experience in Life Sciences Manufacturing OR
BA/BS with 2 years of experience in Life Sciences Manufacturing OR
Equivalent Military training/experience
Manufacturing Associate 5
High School Diploma or GED with 8 years' experience in a Life Sciences Manufacturing environment OR
Associate Degree with 6 years' experience in a Life Sciences Manufacturing environment OR
BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing OR
Equivalent Military Experience
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection.
Be exposed to noisy environments.
Have a normal range of vision
Climb ladders and stairs of various heights.
Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.
Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is .
May be to lift up to 50 pounds on occasion.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
Auto-ApplyManufacturing Associate 3, Drug Product (2nd Shift - 3PM-11:30PM)
Manufacturing associate job in Holly Springs, NC
The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: ***************************************************
Job Description
What You'll Do
• Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control
• Performs in-process testing (pH, conductivity, visual inspection)
• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintains training to perform all required manufacturing activities
• Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area
• Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)
• Assists the lead with tasks in manufacturing activities
• Assists with the coordination of daily shift activities
• This role may require shift work (weekend and potential for nights)
• Performs other duties as assigned
Basic Requirements
• High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment
• Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR
• Bachelor's Degree, preferably Life Sciences or Engineering OR
• Equivalent Military training or experience
Preferred Requirements
• Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection)
• BioWorks or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
Will work in environment operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
Ability to ascend or descend ladders, scaffolding, ramps, etc
Ability to stand for prolonged periods of time
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers
Ability to operate machinery and/or power tools
Ability to conduct work that includes moving objects up to 33 pounds
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
Will work in heights greater than 4 feet
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
Auto-ApplyJt782 - Associate Manufacturing Ns
Manufacturing associate job in Holly Springs, NC
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR] with strict adherence to safety and compliance.
Ensure proper gowning and aseptic techniques are always followed.
Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
Buffer and Media preparation and transfer. Weigh and dispense of materials to be used in the preparation of Buffers and Medias.
Complete washroom activities: cleaning equipment, small to large scale, use in production activities.
Run and monitor critical process per assigned procedures.
Perform documentation for assigned function (i.e., equipment logs, EBRs).
Maintain an organized, clean, and workable space.
Qualifications:
High school diploma / GED + 1 year of manufacturing and/or other regulated experience OR Associate's degree
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding of GMP principles
Strong verbal and written communication skills
Proficient Microsoft Office skills
Ability to follow detailed work instructions (SOPs)
Initial schedule will be Monday-Thursday or Tuesday -Friday, 10 hours days.
The schedule will transition to shifts (rotating 2-2-3, 12 hour shifts) upon completion of startup activities and as business needs dictate.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Auto-ApplyManufacturing Associate
Manufacturing associate job in Holly Springs, NC
Manufacturing Holly Springs, NC, US + Added - 09/12/2025 Apply for Job Pay Rate Low: 18.00 | Pay Rate High: 20.00 Our client, a renowned leader in biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement.
We are seeking a Manufacturing Associate to join our dynamic team and support GMP drug substance manufacturing and validation activities. This individual will play a crucial role in manufacturing operations, ensuring compliance with industry standards while contributing to process optimization and data analysis.
Location: Raleigh/Apex, NC
Contract to Hire
Pay: 18-20/hr.
**Key Responsibilities**
+ Execute manufacturing operations and support activities on the production floor.
+ Perform GMP and non-GMP production runs (small- and large-scale).
+ Handle material preparation, equipment setup, and cleaning validation in compliance with GMP guidelines.
+ Assist in process validation and technical support for manufacturing activities.
+ Collect and analyze data related to manufacturing performance and validation.
+ Support documentation processes, including batch records and deviation reports.
+ Collaborate with cross-functional teams (Engineering, Process Development, and Quality Assurance) to optimize manufacturing workflows.
+ Contribute to continuous improvement efforts and best practices in drug substance manufacturing.
**Education & Experience Options:**
+ High School Diploma/GED + 4 years of relevant work experience
+ Associate's Degree + 2 years of relevant work experience
+ Bachelor's Degree + 6 months of relevant work experience
**Required Skills:**
+ Hands-on experience in GMP technical support, validation, engineering, or process development.
+ Knowledge of drug substance manufacturing processes.
+ Exposure to project management and process improvement initiatives.
**Preferred Skills:**
+ Experience with equipment and cleaning validation.
+ Proficiency in data analysis and visualization tools.
+ Strong technical writing skills for documenting manufacturing processes and validation reports.
**Why Join Us?**
Opportunity to work on cutting-edge drug manufacturing processes.
Hands-on experience in a regulated GMP environment.
Collaborative, growth-focused team with opportunities for career advancement.
If you are detail-oriented, eager to contribute to high-quality manufacturing processes, and excited about making an impact in the pharmaceutical industry, we encourage you to apply!
** **_This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**_**
\#LI-DNP
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Associate III, Downstream Manufacturing
Manufacturing associate job in Sanford, NC
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Purpose and Scope:
The Associate III, Downstream Manufacturing, will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer collaboration. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
Essential Job Responsibilities:
Perform all manufacturing operations under cGMP/ISO requirements while displaying a proficient understanding of downstream process theory (e.g., tangential flow filtration, chromatography) equipment operation, and aseptic processing
Assist with the installation, commissioning, and validation of equipment within single use facility
Adhere to manufacturing GMP documentation guidance (e.g., standard operating procedures) with a proven ability to identify clarifications / updates as well as assist with document updates / generation when required
Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process and maintain a high level of quality and compliance with regards to all aspects of manufacturing in both personal actions as well as through the training of other manufacturing associates
Ability to identify and escalate process non-conformances based on process guidance documents, specified operating limits, and performance metrics tracking
Able to contribute cross departmentally through upstream operation support assignments that fall outside of downstream responsibilities
Often assigned in a support role to internal and cross-functional project teams
Lead the completion of routine non-process operations including, but not limited to, preventative maintenance work order execution and safety walkthrough audits
Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
Quantitative Dimensions:
The Associate III, Downstream Manufacturing, will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.
Organizational Context:
The Associate III, Downstream Manufacturing, will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.
Manufacturing Associate - Biologics (Multiple Openings) - DAY SHIFT
Manufacturing associate job in Holly Springs, NC
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately 6:00AM-6:00PM).
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.
*** Please note that this posting represents multiple openings within our manufacturing organization ***
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: ***************************************************
Job Description
What You'll Do
During the project phase, you may:
Participate and support testing activities, such as: FAT, PQ etc.
Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)
Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing
Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Once we are operational, you may:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control
Perform operations of functional area
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own or establish processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure your own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Basic Requirements
Manufacturing Associate 2
High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR
Associate's Degree in Life Sciences with 0 years of related experience OR
Equivalent Military training/experience
Manufacturing
Associate 3
High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR
Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR
BA/BS in Life Sciences with 0 years of experience OR
Equivalent Military training/experience
Manufacturing Associate 4
High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR
Associate degree with 4 years' experience in Life Sciences Manufacturing OR
BA/BS with 2 years of experience in Life Sciences Manufacturing OR
Equivalent Military training/experience
Manufacturing Associate 5
High School Diploma or GED with 8 years' experience in a Life Sciences Manufacturing environment OR
Associate Degree with 6 years' experience in a Life Sciences Manufacturing environment OR
BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing OR
Equivalent Military Experience
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection.
Be exposed to noisy environments.
Have a normal range of vision
Climb ladders and stairs of various heights.
Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.
Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required.
May be required to lift up to 50 pounds on occasion.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
Auto-ApplyManufacturing Technician I - Power Factor Correction (PFC)- 1st Shift
Manufacturing associate job in Fayetteville, NC
Eaton's ES AMER ARS PDCAD division is currently seeking a Manufacturing Technician I - Power Factor Correction (PFC)- 1st Shift at our Fayetteville, NC facility! Shift Hours: 5:00am - 3:30pm Monday - Friday is $16.00 per hour.
Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations.
What you'll do:
This Manufacturing Technician I - Power Factor Correction (PFC) will assemble, fit and mount sub-assemblies, components, and standard and near standard fixed assemblies in Motor Control Centers, Enclosed Control and related assemblies and sub-assemblies. Perform assembly required for test preparation and final inspection. Assemble and wire units, relay panels, panel boards, space heaters, and control panels. Bend and install power cable and leads, fabricate pre-cable unit, panel and MTB harnesses, and power leads. Use established power checking procedures and equipment to verify electrical/mechanical integrity of units assembled. Stage parts for customer orders.
In this function you will:
* Work from oral or written instructions from supervision and/or prints, inspection reports, manufacturing information sheets, and standard or near standard wiring diagrams.
* Utilize manufacturing information sheets, determine necessary parts, write requisitions, and obtain materials from stock areas.
* Read shop orders and drawings to determine assembly procedures such as component types and configuration, mounting locations and clearances required.
* Assemble and fit parts and components to form sub-assemblies, or completed assemblies.
* Assemble and wire control devices, cutting wires to length.
* Make adjustments to insure correct alignment and clearances.
* Install units, pan assemblies and cover up steel, meters, kirk keys, pull boxes, reactors, relays, fuses, MTB assemblies, panel boards, space heaters, transformers, etc. by mounting / bolting into place. Assemble and install bus work such as lug adapters, cross over bus, splices, etc.
* Make pre-bent cable unit, MTB and control panel harnesses using pre-cable boards, control panels and hand crimp lugs if necessary. Cut, install and connect wire and/or cable in units where circuitry requires additional relays, timers, fuses, etc. Cut, form and connect control wire, power wire and cable, point to point on units, relay panels, control panels, and space heaters
Qualifications:
Required Qualifications:
* High school diploma or GED.
* Eaton will not consider applicants for employment immigration sponsorship or support for this position. This means that Eaton will not support any CPT, OPT, or STEM OPT plans, F-1 to H-1B, H-1B cap registration, O-1, E-3, TN status, I-485 job portability, etc.
* No relocation benefit is offered for this position. Candidates must reside within a 50 mile radius of Fayetteville, NC to be considered
Preferred Qualifications:
* Manufacturing or assembly experience preferred
Position Criteria:
* A basic understanding of electrical / electronic concepts and ability to read and understand standard electrical control circuits
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
Eaton considers qualified applicants regardless of criminal histories, consistent with local laws. To request a disability-related reasonable accommodation to assist you in your job search, application or interview process, please call us at ************** to discuss your specific need. Only accommodation requests will be accepted by this phone number.
We know that good benefit programs are important to employees and their families. Eaton provides various Health and Welfare benefits as well as Retirement benefits, and several programs that provide for paid and unpaid time away from work. Click here for more detail: Eaton Benefits Overview. Please note that specific programs and options available to an employee may depend on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Production Worker (nights)
Manufacturing associate job in Pembroke, NC
Job DescriptionLine Worker (PM Shift)
12-hour shift
1st Shift- $13.55-$15.05 Hourly
Opportunity Overview Dessert Holdings is the leading premium dessert company in the world. We craft artisanal, scratch-made desserts at scale, combining culinary innovation with the finest real ingredients. With a rich heritage spanning seven distinctive brands, we bring unmatched expertise and tailored solutions to our Retail and Foodservice partners.Our location in Pembroke, NC has an opening for a Line Worker.Job responsibilities:
Performs assignments in accordance with established Good Manufacturing Practices (GMP) policies and procedures
Performs assignments in accordance with specifications, instructions, and requirements
Demonstrates ability to meet production standards on specific assignments within required time
Ensures that work ethic provides a positive influence on the Production floor
Maintains good housekeeping and clean work areas in assigned space
Follows Production dress code standards and maintains good personal hygiene
Reports all Production waste to Production Lead or Supervisor
Responsible for food safety and food quality throughout production
Responsible for notifying a Production Lead or Supervisor when they step off the line to ensure food safety and food quality standards are maintained
Understands the management of Quality Systems and is familiar with SQF, HACCP, and GMP practices which help ensure the safety within the workplace and the production of a safe and quality product(s)
Performs other duties as required by Supervisor or Manager
Follows all company policies and procedures
Who You Are:
Must have reliable transportation and be able to work a flexible schedule
Must be willing to work overtime, including weekends if necessary
Must be able to read and write in either English or Spanish
Must be able to work in a fast paced, team environment
Demonstrates good verbal communication skills
Able to stay focused in a loud working environment
Must be able to work in a manufacturing environment requiring strict work/safety rules 100% of the time
About Dessert Holdings
Dessert Holdings is a collection of premium dessert companies and brands: The Original Cakerie, Lawler's Desserts, Atlanta Cheesecake Company, Steven Charles, Dianne's Fine Desserts, Kenny's Great Pies, and Willamette Valley Pie Company. Dessert Holdings is owned by Bain Capital, is headquartered in St. Paul, MN, employs more than 3,500 people across ten manufacturing facilities, and is continuing its journey of rapid growth.
EEO Statement
Dessert Holdings and its related entities provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or any other characteristics protected by law.
Production Worker - General Construction/Production
Manufacturing associate job in Pembroke, NC
Good Life Begins With A Good Company. Champion Home Builders, Inc. wants YOU! We are seeking to hire a Production Worker to join our team in the Pembroke, NC region. WHAT DO WE OFFER? · 401k Plan with Company Match · Paid Vacation · Paid Holidays · Medical
· Rx
· Dental, Vision, and Life Insurance.
WHO IS CHAMPION HOME BUILDERS, INC.?
For decades, Champion has served as a leader in the manufactured housing industry and one of the largest mobile and modular home builders in North America. Champion offers many factory-built solutions, from single-family and multi-family homes to commercial and government buildings. Our manufactured homes, modular homes, mobile homes, park models, and commercial modular buildings can be found throughout the United States and western Canada.
Throughout the organization, we act with integrity and respect. We take pride in our craftsmanship and build strong relationships with our customers, suppliers, and our employees. We know that we would not be successful without our team. In return for hard work and dedication, our goal is to provide a safe, productive, and enjoyable workplace for every employee.
Production Worker
FLSA Status: Non-exempt
Summary Under General supervision, work on the production line to build manufactured
housing, as part of a team, and perform quality work at a fast moving and consistent manner.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Performs all manual labor in the area to which assigned.
• Keeps area neat and clean.
• Read and use a tape measure
• Read blue prints and orders
• Communicate well with coworkers
• Use hand tools, air tools, and electrical tools
Competencies
• Must have a strong work ethic
• Must have the ability to work quickly and methodically
• Must understand safety procedures
• Must have good teamwork skills
• Must live the Champion Operating Principles
Qualifications
• Less than high school education; or up to one month related experience or training; or
equivalent combination of education and experience.
• Previous experience in manufacturing/modular housing desired.
Physical Demands The physical demands described here are representative of those that must be
met by an employee to successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential
functions.
While performing the duties of this Job, the employee is regularly required to stand; use hands to
finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently
required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must
frequently lift and/or move up to 50 pounds and occasionally lift and/or move more than 100
pounds. Specific vision abilities required by this job include close vision, distance vision, color
vision, peripheral vision, depth perception and ability to adjust focus.
ACHIEVE YOUR DREAMS WITH US AND APPLY NOW!
EEO Statement
Champion Home Builders is proud to be an equal-opportunity employer. All qualified applicants will
receive consideration for employment without regard to race, color, religion, gender, gender identity or
expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other
legally protected characteristics. Champion Home Builders participates in the E-Verify Program
Production Operator
Manufacturing associate job in Fayetteville, NC
Summary/objective
Production Operators take parts coming off injection and/or blow molding presses, trim and deflash extra plastic as needed, add secondary elements such as foam and clips as needed, inspect for quality and report defects, and pack parts according to shipping specifications. Production Operators will also clean and sweep production area as needed along with performing other duties as assigned.
Essential functions
Follow specific instructions for the manufacturing of each part.
Inspect parts for errors and defects to ensure all parts meet specifications and standards.
Pack parts according to quality instructions.
Physical Requirements
While performing the duties of this job, the employee is regularly required to work standing up, walk, use hands and fingers to operate tools and equipment, and speak and listen to fellow employees in order to perform the above listed duties. The employee frequently is required to reach with hands and arms and may need to stoop, kneel, or crouch. The employee must regularly lift and/or move up to 15 pounds and frequently lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Work environment
Non-temperature controlled manufacturing production floor. Must be able to work in an extreme heat or cold environment.
First Brands Group is a proud equal opportunity employer. We are deeply committed to building a workplace and global community where inclusion is valued. Employment decisions at FBG are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, or belief, national, social, or ethnic origin, sex, or age. All qualified applicants will be considered for employment without regard to the above forementioned as well as, gender, gender identity family/marital status, sexual orientation, national origin, age, past or present military veteran status, or any other non-merit based or legally protected grounds. FBG will not tolerate discrimination or harassment based on any of these grounds or characteristics.
Auto-ApplyManufacturing Technician I (Harness) - 1st Shift
Manufacturing associate job in Fayetteville, NC
Eaton's ES AMER ARS PDCAD division is currently seeking a Manufacturing Technician I (Harness) - 1st Shift. Shift hours:6:00am - 2:30pm Monday - Friday. Overtime may exceed these hours, and can be mandatory at times. is $16.00 per hour, plus a $1/ hour icrease for 2nd shift.
Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations.
What you'll do:
The Manufacturing Technician II (Harness) will assemble, fit and mount sub-assemblies, components, and standard and near standard fixed assemblies in Motor Control Centers, Enclosed Control and related assemblies and sub-assemblies. They will also perform assembly required for test preparation and final inspection. They will assemble and wire units, relay panels, panel boards, space heaters, and control panels. They will bend and install power cable and leads, fabricate pre-cable unit, panel and MTB harnesses, and power leads. They will use established power checking procedures and equipment to verify electrical/mechanical integrity of units assembled. They will stage parts for customer orders.
In this function you will:
A. Work from oral or written instructions from supervision and/or prints, inspection reports, manufacturing information sheets, and standard or near standard wiring diagrams.
B. Utilize mfg. information sheets, determine necessary parts, write requisitions, & obtain materials from stock areas.
C. Read shop orders and drawings to determine assembly procedures such as component types and configuration, mounting locations and clearances required.
D. Assemble and fit parts and components to form sub-assemblies, or completed assemblies.
E. Assemble and wire control devices, cutting wires to length.
F. Make adjustments to insure correct alignment and clearances.
G. Install units, pan assemblies and cover up steel, meters, kirk keys, pull boxes, reactors, relays, fuses, MTB assemblies, panel boards, space heaters, transformers, etc. by mounting / bolting into place. Assemble and install bus work such as lug adapters, cross over bus, splices, etc.
H. Make pre-bent cable unit, MTB and control panel harnesses using pre-cable boards, control panels and hand crimp lugs if necessary. Cut, install and connect wire and/or cable in units where circuitry requires additional relays, timers, fuses, etc. Cut, form and connect control wire, power wire and cable, point to point on units, relay panels, control panels, and space heaters. Make solder connections.
I. Modify standard assemblies or doors as received. May alter hole cutouts, etc. using hand or power tools.
J. Make wiring changes as required. Make necessary mechanical repairs, replacements or changes. Use buzzer as required, to assure proper wiring connections.
K. Use floor operated overhead and jib cranes. Move units, harnesses, device panels, etc. from one area to another.
L. Determine the quality of work reporting problems to area supervisor or Quality Control personnel. Maintain piece count and associated records where applicable.
M. Mark wires, devices or terminals as required. Identify harness and/or panels with job and unit number. Apply component ID labels such as "Brady Markers" or "Dymo" labels if required. Identify work and maintain records.
N. Wear all safety equipment and observe all hygiene requirements as specified and directed.
O. Maintain equipment and work areas in a clean and orderly manner.
P. From information provided, stage necessary component parts / material in a manner which allows for the smooth flow of order activities through the assembly / manufacturing process.
Q. Other duties as assigned.
Qualifications:
Required (Basic) Qualifications:
• High school diploma or GED from an accredited institution
• Eaton will not consider applicants for employment immigration sponsorship or support for this position. This means that Eaton will not support any CPT, OPT, or STEM OPT plans, F-1 to H-1B, H-1B cap registration, O-1, E-3, TN status, I-485 job portability, etc.
• No relocation benefit is offered for this position. Candidates must reside within a 50 mile radius of this location
Preferred Qualifications:
• Minimum of 3 months previous experience in manufacturing environment
• Experience reading schematic drawings/ blueprints
Position Criteria:
• Work with individuals and groups to effectively participate within team environment.
• Willing to work flexible hours and overtime in support of business needs.
• Demonstrated comprehension of wiring diagrams and schematics.
• Utilize various hand tools to assembly and wire products in a lean environment.
• Self-driven and able to produce desired results with minimal direction.
• Able to stand; walk; sit; reach at or above shoulder level; grip; and use hands to handle and feel.
• Able to frequently lift/carry up to 35 pounds.
• Able to push/pull up to 35 pounds.
• Adequate far and close vision with depth perception and color discrimination.
#LI-SD1
#IND123
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
Eaton believes in second chance employment. Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act and other local laws.
You do not need to disclose your conviction history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report.
To request a disability-related reasonable accommodation to assist you in your job search, application, or interview process, please call us at 1-800-###-#### to discuss your specific need. Only accommodation requests will be accepted by this phone number.
We know that good benefit programs are important to employees and their families. Eaton provides various Health and Welfare benefits as well as Retirement benefits, and several programs that provide for paid and unpaid time away from work. Click here for more detail: Eaton Benefits Overview. Please note that specific programs and options available to an employee may depend on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Packaging Tech I - Wicked Weed Brewing
Manufacturing associate job in Candor, NC
Dreaming big is in our DNA. It's who we are as a company. It's our culture. It's our heritage. And more than ever, it's our future. A future where we're always looking forward. Always serving up new ways to meet life's moments. A future where we keep dreaming bigger. We look for people with passion, talent, and curiosity, and provide them with the teammates, resources and opportunities to unleash their full potential. The power we create together - when we combine your strengths with ours - is unstoppable. Are you ready to join a team that dreams as big as you do?
Job Title: Packaging Technician
Department: Packaging
Location: Wicked Weed Brewing
Reports To: Packaging Manager
Supervisory Responsibilities: This job has no direct supervisory responsibilities.
Summary:
At Wicked Weed Brewing, we craft different to create better experiences that UNITE people and ENRICH communities. We strive continuously to create a safe and inclusive workplace while supporting our communities and reducing our environmental impact. We celebrate unique perspectives and experiences that everyone brings, fostering a culture where employees are valued and empowered.
The Packaging Technician works in the Packaging Department to operate and maintain equipment needed to package beer in a variety of containers including kegs, bottles, and cans. Assists in a variety of aspects throughout the business as needed.
Essential Duties and Responsibilities:
Understands and adheres to all safety standards.
Operates packaging department equipment.
Troubleshoot equipment problems within the department.
Cleans and maintains bottling/kegging/canning lines.
Alerts supervisor or other management personnel to potential quality concerns.
Functions well working in a team environment.
Completing computer-based work and training, as required to fulfill job or department duties.
Additional duties may be assigned as necessary.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills and Abilities:
Safety first mindset
Must be willing to work a flexible schedule
Report to Candler, NC or Arden, NC Brewery for packaging work as needed.
Interpersonal skills sufficient to be comfortable working in a team environment with a great deal of interdepartmental coordination.
The ability and aptitude to work with and troubleshoot equipment is important.
The ability to autonomously stay on task and work independently if needed
Basic computer skills including using the internet and using MS Office software.
Eye for detail and high sanitation standards
Drive to learn, grow, and thrive in a continuous improvement environment
Education and Experience:
High school diploma or equivalent
Experience in a production/packaging environment a plus
An understanding of lock-out/tag-out and other core safety issues.
Work Environment:
The work environment is that of a brewery.
The employee regularly works with hazardous machinery, materials, and chemicals.
The employee works on wet floors and with wet equipment.
The employee regularly works around high voltage, hot water, and steam.
Physical Demands:
Ability to handle heavy objects safely and with proper body mechanics - Lift and move objects weighing up to 55 lbs. repetitively
Ability to perform work in a non-temperature-controlled environment.
Ability to be on your feet for long periods of time standing and/or walking. Walking surfaces may be wet and/or slippery.
Ability to frequently sit, stoop, kneel, crouch, crawl and climb.
Ability to frequently talk, hear, and smell.
Ability to frequently reach with hands and arms; use hands to finger, handle or feel objects, tools, or controls.
Vision abilities required by this job include close vision, distance vision, and the ability to adjust focus.
Other Duties:
Please note that this job description is not designed to cover or contain a comprehensive list of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.
Production Operator - $20.50
Manufacturing associate job in Candor, NC
Join our Team at Magnera!
New Starting Rate of $20.50 with a potential to earn up to $25.25 with a pay for skill program.
Apply Now!
Hiring entry level production operators
12-hour swing shifts with 1 week off each month
Annual performance bonuses
Benefits include comprehensive package with 401k employer contribution & paid time off
Background & drug screening required
GED or equivalent require
Under direct supervision, responsible for the daily operations of a non-woven production line ensuring a quality product, maintaining a safe environment, and achieving desired key performance measurements. Processes include opening, carding, entangling, drying, calendaring, winding, slitting and packaging equipment.
Responsibilities
Performs all tasks in a safe manner, complies with all safety rules. Identifies and reports unsafe operations to the Team Lead immediately.
Executes the change over process; set-up the production equipment and supplies before executing job orders; ensures product receipe compliance.
Inspects equipment to identify any replacements, malfucntions, and repairs; recommends improvements.
Brings product samples to the lab per defined inspection plan. Report any quality issue with incoming raw material or finished good materials to the Team Lead and to the Quality team.
Completes all process and quality records as requested. Reports any changes for process parameters, any issues with equipment as needed, to the Team Land and to Process Engineers.
Ensures all process parameters are set as per the recipe or within the acceptable range defind by process to ensure a quality product.
Performs preventative maintenance tasks per defined schedule.
Performs routine or minor maintenance of equipment. Assists to remove jams, to replace belts, and other routine maintenance. Particpates in card repair such as rewiring and card set-ups.
Troubleshoots process and equipment issues using analytical trouble shooting and other tools.
Operates a forklift to move various items in the manufacturing area. Complies with FIFO system for raw materials.
Maintains housekeeping expectations. Complete housekeeping audits and reports findings.
Contributes to waste management programs.
Uses operatoring systems for O&B, carding, entangling, winder, hammermill and slitter operations.
Ensures full traceability by scanning raw material and finished goods.
Attends Tier One meeting and plant wide meetings; Attends all scheduled training.
Complies with hygiene policy and non-conforming materials procedures.
Performs other duties as assigned.
Qualifications
High School Diploma or GED, required.
Good Computer Skills.
Good Mechanical Skills.
Two (2) years manufacturing experience, preferred
Six (6) months forktruck experience, preferred
Competencies
Auto-ApplyManufacturing Specialist - Single Use Systems (SUS)
Manufacturing associate job in Holly Springs, NC
Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Manufacturing Specialist - Single Use Systems (SUS)
What you will do
Let's do this. Let's change the world. In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuous improvement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolina's success and key in supporting single-use (SUS) operations.
Support New Product introduction and projects through SUS mapping/drawing.
Maintain and edit SUS Standard Operating Procedures (SOP).
Support manufacturing and quality through the SUS defect/leak triage process - perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
Provide input for ANC representative to SUS network for improvements and troubleshooting.
Support Vendor Change Notification assessments.
Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications.
Basic Qualifications:
High School/GED and 4 years of manufacturing or operations work experience OR
Associate's Degree and 2 years of manufacturing or operations work experience OR
Bachelor's Degree and 6 months of manufacturing or operations work experience OR
Master's Degree
Preferred Qualifications:
Experience with and understanding of Single-Use Systems.
Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
Ability to coach, mentor and/or cross train colleagues within core technical area.
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
Ability to drive results through leadership of cross-functional teams.
Data analysis and/or data visualization skills
Excellent writing skills. Presentation experience - presentation to leadership.
Determines work tasks and timelines self-sufficiently - ability to navigate through ambiguity and prioritize effectively
Proficiency in computerized systems for example, Smartsheet, excel, Trackwise, Veeva, Visio.
Expertise with translating business/user needs to user requirements and recommend solutions.
Experience in individually supporting key manufacturing systems with 24x7 operations.
The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations.
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
Pro-active, result oriented, and ability to prioritize work to meet timelines.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
88,378.00 USD - 106,188.00 USD
Auto-ApplyManufacturing Technician
Manufacturing associate job in Sanford, NC
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• The person filling this position operates all equipment in two assigned Manufacturing areas.
• He or she will also clean equipment and facilities, and provide documentation of all duties in accordance with Good Manufacturing Practices.
• Incumbent will perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.
• The incumbent will be required to attend quality-training programs and orientations on an annual or as needed basis.
• This individual will be required to become familiar with domestic and international regulatory requirements associated with manufacturing and biological processes.
• Annual performance goals and objectives will be evaluated against specific quality performance requirements as defined by the Manufacturing Supervisor.
• Mandatory commitment to report to management any potential or actual deviations from regulatory requirements.
• Ongoing input regarding quality process improvements.
• Master documentation procedures by following detailed written and verbal instructions in order to complete assigned tasks (follow area SOP s).
• Demonstrate knowledge of procedures by performing tasks and duties and maintaining detailed records in a manner compliant with cGMPs.
• Perform routine job duties, which may include vacuuming, mopping ceilings, walls and floors, emptying trashcans, etc.
• Prepare production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens.
• Clean and sterilize process equipment (tanks, fermentors) as needed.
• Demonstrate and instruct proper gowning and aseptic processing procedures.
• Work with individuals as a team.
• Work various shifts and some weekends.
• Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor.
• Train new employees on production processes.
• Perform lab work, such as: performing sample dilutions, pH, and conductivity readings.
The following combinations of education and work experience are considered acceptable:
• BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience
• AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience
• HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience
• Or progression from Bio-processing Technician Level I. that includes additional internal development curriculum
List certificates (if any) required.
• Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements.
• Must complete training and comply with applicable cGMP requirements.
Minimum number of years of prior experience required to perform job duties.
A minimum of four years pharmaceutical experience in biological manufacturing is preferred.
List specific skills and minimum expertise (ie., typing speed (WPM), fully trained ability to learn, etc.) required to perform
job duties
• Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis.
• Basic understanding of the metric system.
• Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns.
• Must possess mechanical ability to assemble and operate equipment.
• Must pay attention to detail by following procedures and noting unusual conditions.
• Must have written and oral communication to read procedures, write accurate observations and follow directions
Additional Skills:
• GMP experience required
• Pharma experience highly preferred
• Bioprocessing experience in a cGMP environment, knowledge of Clean and Steam in Place Systems, perform facility cleanings, collecting WFI and Clean Steam samples.
• Experience with autoclave and industrial washers
Qualifications
• BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience
• AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience
• HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience
• Or progression from Bio-processing Technician Level I. that includes additional internal development curriculum
Additional Information
Akriti Gupta
Associate Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Manufacturing Specialist Single Use Systems (SUS) - Holly Springs, NC
Manufacturing associate job in Holly Springs, NC
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Manufacturing Specialist - Single Use Systems (SUS) Lead
What you will do
Let's do this. Let's change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, the Manufacturing Specialist will have ownership and oversight of Single Use Systems technology for the Manufacturing area, including generating training materials and / or providing training on scientific or technical aspects of the Single Use Systems. In addition, this role will have the opportunity to be involved on any of the following: Standard Operating Procedure (SOP) creation, review, and approval; develop, manage, and run change controls associated to area of expertise; and complete deviation investigations along with corresponding preventive/corrective action records. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to keep the manufacturing area operational.
Provide technical support and subject matter expertise for Single Use Systems for the manufacturing area.
Oversee and support ongoing development of all the manufacturing systems related to Single Use Systems including SOP, Training, Manufacturing Execution Systems/Batch Records, Quality Management System (e.g. Veeva/Trackwise) records, among others.
Train staff (supervisors, operators, technical/QA/support) on Single Use systems.
Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility
Facilitate process, area, and equipment risk assessments as needed to identify risks, failure modes, and mitigating actions
Engage in regulatory inspections and in the NPI process to assess requirements for documentation, materials, training, and equipment modifications
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the qualifications below.
Basic Qualifications:
High school diploma / GED & 10 years of biotechnology operations experience OR
Associate's degree & 8 years of biotechnology operations experience OR
Bachelor's degree and 4 years of biotechnology operations experience OR
Master's degree in chemistry, biology or engineering and 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in GMP manufacturing operations
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
Background in lean manufacturing methodologies and operational excellence
Strong technical knowledge of Single Use System use at a drug substance company and a broad understanding of related disciplinary areas in bioprocessing
Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff
Experience in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
112,977.00 USD - 139,179.00 USD