Manufacturing Specialist II, Technical Operations
Manufacturing technician job in Parkton, NC
About this Role
In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.
What You'll Do
Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records
management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution.
Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
Initiate, own, and manage manufacturing focused change controls, CAPAs, investigations, and planned exceptions
This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.
Who You Are:
If you are a highly detailed and focused individual who demonstrates a moderate level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.
Qualifications
Required Skills:
Bachelor's degree (Life Sciences or Engineering ) preferred, with 0-1 years of transferrable experience
Associates Degree or Bioworks Certificate and 2 years of transferrable Experience
High School Diploma (or Equivalent) 4 years of transferrable experience
Preferred Skills:
Prior experience in manufacturing - drug product operations
Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
Robust understanding of quality and cGMP principles
Fundamental knowledge of change control in cGMP environment
Intermediate to advanced skills in Microsoft Office and computer-based quality systems
Intermediate to advanced level of technical writing skill
Ability to interpret manufacturing process design documentation
Excellent oral and written communication skills
Job Level: Professional
Additional Information
The base compensation range for this role is: $34.13-$44.23
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 Specialist 2, DP
Manufacturing technician job in Holly Springs, NC
This role as Manufacturing Specialist 2 will performs manufacturing support activities to ensure compliant and reliable production. 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
* During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts.• Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s).• Coordinate Batch Planning including process template creation and import and management of PMs.• Own, perform, or drive documentation major documentation updates (Initiate new documents for new processes)• Coordination of non-batch activities including but not limited to Changeover, PMs, column packing, APS.• Support tech transfer within manufacturing domain.• Ensure compliance and safety procedures are followed in manufacturing environment. • Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities.• Lead large scale improvement projects in DPFG• Assist and support inspections and audits, providing support to ensure compliance within the manufacturing environment.• Assist in creating work schedules for junior staff.• Perform other duties as assigned.
Basic Requirements
* High school Diploma or GED with 12 years of related experience
Preferred Requirements
* Associate degree and 10 years of direct experience OR• BA/BS and 8 years of direct exp OR• Equivalent Military experience • Strong manufacturing operations experience• High degree of understanding of operations sequence and cadence of activities
* Bio Works or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Will work in environment which 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 wrists, 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 warm/cold environments
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 - Hiring Now
Manufacturing technician 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 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.
Manufacturing Technician
Manufacturing technician 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)
Manufacturing technician 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 Specialist Single Use Systems (SUS) - Holly Springs, NC
Manufacturing technician 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
Manufacturing Specialist 2, DP
Manufacturing technician job in Holly Springs, NC
This role as Manufacturing Specialist 2 will performs manufacturing support activities to ensure compliant and reliable production. 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
• During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts.
• Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s).
• Coordinate Batch Planning including process template creation and import and management of PMs.
• Own, perform, or drive documentation major documentation updates (Initiate new documents for new processes)
• Coordination of non-batch activities including but not limited to Changeover, PMs, column packing, APS.
• Support tech transfer within manufacturing domain.
• Ensure compliance and safety procedures are followed in manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities.
• Lead large scale improvement projects in DPFG
• Assist and support inspections and audits, providing support to ensure compliance within the manufacturing environment.
• Assist in creating work schedules for junior staff.
• Perform other duties as assigned.
Basic Requirements
• High school Diploma or GED with 12 years of related experience
Preferred Requirements
• Associate degree and 10 years of direct experience OR
• BA/BS and 8 years of direct exp OR
• Equivalent Military experience
• Strong manufacturing operations experience
• High degree of understanding of operations sequence and cadence of activities
• Bio Works or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which 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 wrists, 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 warm/cold environments
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-ApplyQuality Technician I
Manufacturing technician job in Garner, NC
Job Description
Knapheide Installation Center in Raleigh, NC is looking to hire a Quality Technician I to evaluate the overall quality of the completed units produced at the facility. This full-time position works Monday - Thursday from 6:30 AM - 3:30 PM.
At Knapheide, you're more than an employee. You're part of a family filled with multi-generation employees who take pride in the work they do. Knapheide has been in business since 1848 and is the premier work truck equipment, accessory, and commercial upfit provider in the United States.
BENEFITS & PERKS
Paid time off
Paid holidays, including Black Friday and Christmas Eve
401(k) with 7% company contribution, once eligible
Medical, dental, and vision insurance
Employer paid life insurance
DAY TO DAY AS A QUALITY TECHNICIAN
As a Quality Technician I, you'll inspect units to ensure the final product meets quality standards for form, fit, and function and matches the customer order. You'll work with the production team to ensure repairs are completed in a timely manner in order to maximize customer satisfaction. You'll assist in communicating quality issues throughout the organization in order to prevent further occurrences. To be successful in this role, you'll need to be detail oriented and have a strong mechanical background.
OUR IDEAL CANDIDATE
Career-minded - looking for more than a job
Team player - gets along well with others
Organized & attentive to detail - nothing gets by you without being double-checked
Efficient - a knack for effectively prioritizing tasks and managing your time
REQUIREMENTS
High School Diploma or GED Equivalent; Associates or Bachelor's Degree preferred
Previous experience working in a Quality role preferred
Ability to lift/move up to 75 pounds
If you're someone who never settles for second best, takes pride in the work you do, and you're looking for a jump start on a new career, apply today!
Associate III, Downstream Manufacturing
Manufacturing technician 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.
**Qualifications**
**Required:**
+ BS / BA in Chemical/ Biological Engineering or Life Sciences with 2+ year of applicable industry experience or associate's degree in science with 3+ years of industry experience or H.S. diploma with 4+ years of industry experience
+ Understanding of cGMPS as related to commercial and clinical operations
+ Experience in maintaining detailed records and ability to assist in document revisions
+ Strong communicator with ability to work effectively both independently and as part of a team along with effective problem-solving skills
+ Strong computer skills including MS Office (Word, Excel)
+ Proven ability to establish and maintain effective working relationships with team members and managers
+ Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Will support and demonstrate quality standards to ensure data of highest quality
+ Strong communicator with the ability to work independently and closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work
+ Will be expected to perform other duties and/or special projects, as assigned
**Preferred:**
+ BioWork Certification or related certification along with technical understanding of a biotech manufacturing facility is a plus
+ Proficient understanding of protein purification and technique
+ Experienced in Startup of a new facility
+ Experience with single-use technologies
+ Understanding of FDA regulations
+ Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
+ Ability to support general investigations and CAPA execution
+ Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
**Working Conditions:**
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching overhead activities, and independent mobility to lift to 25lbs
+ This is an on-site role working in a cGMP regulated manufacturing facility
+ On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
+ Work Schedule: Mon-Thurs. 6am - 4pm.
**Salary Range** : $35.00 - 55.00 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
**Benefits** :
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company fleet vehicle for eligible positions
+ Referral bonus program
\#LI-TR1
Category Sanford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
1st shift Production Technician II (Monday-Thursday 6:00 am-4:00 pm)
Manufacturing technician job in Apex, NC
Who we are:
Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.
About the role:
The Production Technician II is responsible for manufacturing high-quality products. Production Technicians will primarily work on assemblies and sub-assemblies for production and development product lines. This role is a key contributor to the team's continuous improvement efforts in achieving monthly production metrics and in safety, quality, sustainability, and production costs.
1st shift Monday-Thursday 6:00 am-4:00 pm
What you will do:
Manufacture and assemble products and sub-assemblies within product specifications and close tolerances for both production and development products.
Follow all Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) when completing daily tasks.
Use production travelers and other documentation to identify and confirm raw material accuracy prior to starting manufacturing runs.
Assist senior-level operators with loading machines, positioning of material, and setting up assembly runs.
Locate and document production metrics such as yield amounts, tolerance levels, and quality of materials.
Assist in initial visual inspection of completed manufacturing runs by operating precision measuring equipment.
Assist with the cleaning of all cleanroom areas including applicable gowning rooms.
Who you are:
High School Diploma or equivalent required
Two(2) to Three (3) years of experience in a manufacturing or cleanroom environment
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Knowledge and ability to solve mathematical equations that include addition, subtraction, multiplication, and division of all units of measure
Ability to effectively communicate and collaborate amongst co-workers and cross-functional teams
Ability to read and interpret working documents such as blueprints, machine manuals, Standard Operating Procedures (SOPs), and batch records
Experience using Microsoft Office Suite
Perks / Benefits:
Generous Paid Time Off
Paid Breaks
Annual Bonuses
401k with excellent company match
Health Insurance with multiple plans to choose form
Paid Short Term and Long Term Disability
Process Technician - Manufacturing Support/Material Prep
Manufacturing technician job in Parkton, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Responsibilities:
The Operator/Technician will support commissioning/qualification activities required to bring material prep suites into service as well as supporting site operational activities. This position may require domestic travel with the potential of international travel based on program need.
This role will be responsible for execution of daily material prep operations tasks defined by the shift lead/supervisor.
Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleanings, etc.).
Attain and maintain qualification for the operation of assigned process equipment and duties in the area.
Identify opportunities for operational improvements.
Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Must be willing to work 12-hour shifts (2-2-3 schedule)
Candidate must be flexible and be willing to perform non-routine work with Safety & Integrity in mind at all times
Provide commissioning, qualification, and operational readiness support during project phase.
Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Formulation area.
Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.)
Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Basic Requirements:
High School Diploma or equivalent.
Additional Skills/Preferences:
Knowledge of current Good Manufacturing Practices (CGMPs).
Previous experience working in operations/pharmaceutical industry.
Previous experience compounding/formulation in a Grade C environment.
Previous experience using solution filling equipment and/or isolator technology.
Ability to effectively communicate (written and verbal).
Knowledge of lean manufacturing principles.
BioWork Certification.
Additional Information:
Ability to wear safety equipment required (safety glasses, safety shoes, protective gloves etc.).
Ability to gown and work in controlled classified areas (grade c and grade d).
Basic digital literacy (desktop software) is required.
Must pass a “fitness for duty” physical exam.
Ability to work 12-hour shifts on days (2-2-3 schedule) with additional overtime as the need arises.
Project phase will require a baseline 5-day work week with flexibility to adjust hours to support specific project tasks.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$17.30 - $38.08
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyProduction Technician - NC #2684
Manufacturing technician job in Garner, NC
Title Production Technician - NC #2684
Worldwide manufacturing company with operations in North Carolina. The strength of the organization is a focus on continuous innovation and investments in both product and technological developments.
. Complies with all company safety rules and procedures.
. Monitors and reacts in a timely manner to routine demand maintenance requirements.
. Participates in routine Preventative/Predictable Maintenance.
. Troubleshoots equipment stoppages and reacts accordingly.
. Utilizes various mechanical and electrical test equipment.
. Assists with manufacturing during product change-over.
. Plans, assists, documents, and implements process improvement techniques and devices.
. Utilizes machining, electrical and mechanical trade skills to complete daily tasks.
. Communicates with production and other various customers as needed.
. Performs other tasks as assigned by management.
. Formal training and practical experience in an industrial setting as a Production Technician.
. Associates degree in applied technology in industrial/manufacturing or equivalent experience
. 3-5 years practical hands on experience in an industrial setting
. Experience with high pressure hydraulics, pneumatics, and automated material handling utilizing 480vac VFD's, and PLC control logic troubleshooting
. Good mechanical aptitude
. Ability to work with minimal supervision on various optimization projects from conception to completion
. Ability to produce technical reports and update drawings
. Light machining and welding skills
. Light fabrication skills
. Good verbal and written communication skills
. Able to interpret and produce mechanical and electrical drawings and schematics
Bottom line requirements we need notes on with candidate submittal:
1. Formal training in an industrial setting as a Production Technician.
2. Associates degree in applied technology in industrial/manufacturing or equivalent experience.
3. 3 + years practical hands on experience in an industrial setting.
4. Experience with high pressure hydraulics, pneumatics, and automated material handling utilizing 480vac VFD's, and PLC control logic troubleshooting.
5. Ability to troubleshoot complex multi-machine production line.
6. Preventative Maintenance, High Speed Manufacturing, and Packaging experience are pluses.
Additional Information
All your information will be kept confidential according to EEO guidelines.
1st shift Production Technician II (Monday-Thursday 6:00 am-4:00 pm)
Manufacturing technician job in Apex, NC
Job Description
Who we are:
Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.
About the role:
The Production Technician II is responsible for manufacturing high-quality products. Production Technicians will primarily work on assemblies and sub-assemblies for production and development product lines. This role is a key contributor to the team's continuous improvement efforts in achieving monthly production metrics and in safety, quality, sustainability, and production costs.
1st shift Monday-Thursday 6:00 am-4:00 pm
What you will do:
Manufacture and assemble products and sub-assemblies within product specifications and close tolerances for both production and development products.
Follow all Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) when completing daily tasks.
Use production travelers and other documentation to identify and confirm raw material accuracy prior to starting manufacturing runs.
Assist senior-level operators with loading machines, positioning of material, and setting up assembly runs.
Locate and document production metrics such as yield amounts, tolerance levels, and quality of materials.
Assist in initial visual inspection of completed manufacturing runs by operating precision measuring equipment.
Assist with the cleaning of all cleanroom areas including applicable gowning rooms.
Who you are:
High School Diploma or equivalent required
Two(2) to Three (3) years of experience in a manufacturing or cleanroom environment
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Knowledge and ability to solve mathematical equations that include addition, subtraction, multiplication, and division of all units of measure
Ability to effectively communicate and collaborate amongst co-workers and cross-functional teams
Ability to read and interpret working documents such as blueprints, machine manuals, Standard Operating Procedures (SOPs), and batch records
Experience using Microsoft Office Suite
Perks / Benefits:
Generous Paid Time Off
Paid Breaks
Annual Bonuses
401k with excellent company match
Health Insurance with multiple plans to choose form
Paid Short Term and Long Term Disability
Production Technician 1
Manufacturing technician job in Lillington, NC
$12.00 - $13.00/hr. based on experience
General Duties and Responsibilities
The following general duties apply to all specialty areas within the Production Technician II position.
Safely handling materials, tools, and supplies used in the department.
Determining if the product that is being manufactured has the correct parts and is correctly cut and processed to ensure a quality product.
Performing some minor machine maintenance as required.
Recognizing immediately if a machine is malfunctioning and notifying group leader promptly to avoid delays in production.
Meeting schedules and maintaining good quality requirements on a daily basis.
Filling in on any position on the production floor as required by the group leader or any other designated employee if need should arise.
Receiving requests, instructions and directions and complying with the same.
Complying with all safety rules and regulations and using any personal protective equipment or machine guards that may be required.
Keeping a safe, clean and well-organized workstation.
Recognizing any hazards or unsafe situations in the department and making suggestions to the group leader of any methods or procedures to correct the problem.
Recognizing any defect in product and reporting defect to group leader after sending to next operation.
Being proactive by regularly making suggestions for job improvements, product quality, housekeeping, etc.
Keeping equipment and tools stored in their correct places.
Notifying the group leader immediately if shortages of supplies should arise.
Knowledge of Material Safety Data Sheets (MSDS).
Other duties as assigned by management.
Job Duties of Edge Trimmer
The employee will perform on a regular basis
Using edge-trimming tool to trim raw edges of leather to ensure product has smooth edge for proper finishing.
Adhering to quality requirements for every product that requires trimming.
Using knowledge of leather and synthetic materials, parts, and products to ensure quality and proper product manufacture.
Job Duties of Gluer
The employee will perform on a regular basis.
Gluing by means of brushing, spraying or glue dots.
Using knowledge of accessory assemble and manufacture stages regarding gluing.
Cleaning glue off product if needed.
Filling glue containers as needed.
Using knowledge of leather and synthetic materials, parts, and products to ensure quality and proper product manufacture.
Job Duties of Riveter
The employee will perform on a regular basis.
Safely operating Milford press rivet machine or any other rivet machine (electric or manual) as required.
Safely riveting belts, accessories, holsters, etc. as required.
Using knowledge of products to choose correct size plates and rivets for each product.
Using drill press to drill out any defective rivets or for any other repair work.
Setting up snaps and studs on holster, accessories, etc.
Knowledge/Skills/Experience
1 year of general manufacturing experience preferred.
Requires basic math skills sufficient for each specialty area, which includes addition, subtraction, multiplication, and division.
Basic reading and writing skills required.
Use of Machines, Tools, and Equipment
The employee will use some or all of the following:
Calculator
Shears
Razor knives
Various mechanical machines
Various cleaners, oils, etc.
Other hand and power tools as needed
Work Environment
Manufacturing facility
Primary work area is a work station
Climate controlled environment
Attire must meet requirements as set forth in the General Safety Guidelines.
Physical Requirements
Ability to lift up to 30 lbs. on a regular basis and 60 lbs. occasionally.
Ability to pick, pinch, hold, turn, grip, grasp, feel and work with both hands, arms or shoulders on a daily basis.
Use of fingers, hands, arms, legs and feet to accomplish tasks.
Able to lift, push, pull, sit, walk, and stand as needed.
Ability to carry, lift, push, pull, step, climb, reach with hands and arms; bend, stoop and kneel.
Ability to stand or sit for long periods of time on a regular basis.
Ability to move quickly around in all areas of the facility.
High energy level appropriate to fast-paced environment.
Ability to work with glues, oils, and cleaners (and possibly other chemical substances).
Adequate vision to accomplish tasks listed in this , including ability to identify and distinguish colors and high level of detail.
Adequate hearing to understand directions.
This is intended to provide general information regarding this position and is not intended as a complete list of all job duties.
As with all positions, the responsibilities, duties, and requirements of this job may change. The company may alter job descriptions at any time, with or without notice
.
Senior Millwright/Electromechanical Technician (2nd Shift)
Manufacturing technician job in Laurinburg, NC
Job Description
2nd Shift Senior Millwright / Electromechanical Technician
The Senior Millwright / Electromechanical Technician is responsible for safely and efficiently troubleshooting, repairing, and maintaining plant machinery and equipment. This role plays a key part in ensuring optimal production performance through both preventive and emergency maintenance activities.
Key ResponsibilitiesMaintenance
Perform scheduled and emergency repairs of production equipment to minimize downtime.
Prepare and set up machinery for scheduled production runs.
Troubleshoot and repair mechanical, electrical, pneumatic, and hydraulic systems on packaging and production machines.
Conduct preventive maintenance (PM) on all plant equipment.
Read and interpret technical manuals, blueprints, and work orders to complete required maintenance tasks.
Safely operate mobile equipment such as forklifts, front loaders, telehandlers, skid steers, man lifts, and yard/jockey trailers.
Perform other related duties as assigned.
Quality
Ensure all current quality assurance measures are followed and communicated effectively to supervisors, production staff, drivers, and customers.
Assist in the development and implementation of new maintenance and quality procedures as needed.
Safety and Administration
Comply with all OSHA Safety and Health regulations.
Maintain a clean, safe, and organized maintenance work area.
Communicate effectively with supervisors and fellow maintenance personnel.
Administer and enforce company maintenance policies.
Conduct safety-related tests and inspections to meet regulatory and insurance requirements.
Participate in monthly safety meetings and continuous improvement initiatives.
Physical Requirements
Ability to lift 2550 lbs. regularly.
Ability to respond quickly to sounds and safety cues.
Capable of working safely in confined spaces or on uneven terrain.
Comfortable working in varying weather conditions.
Must correctly wear personal protective equipment (PPE) at all times.
Other Duties
Support the Maintenance Supervisor and Manager with ongoing projects and plant improvement initiatives.
Qualifications
High School Diploma or Technical Degree required.
Minimum of 10 years of industrial maintenance experience in a manufacturing environment.
Strong organizational and troubleshooting skills.
In-depth knowledge of hydraulic, pneumatic, and electrical systems.
PLC programming and troubleshooting experience preferred.
Manufacturing Specialist 1, Drug Product
Manufacturing technician job in Holly Springs, NC
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
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, support operational readiness initiatives as well as site commissioning and qualification efforts• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)• Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)• Owns, performs, or drives documentation major documentation updates (i.e. Initiates new documents for new processes)• Coordinates non-batch activities (e.g., Changeover, PMs, Aseptic Process Simulation [APS])• Supports the MSAT group with tech transfer within manufacturing• Ensures compliance and safety procedures are followed in manufacturing environment• Create and updates Electronic Batch Records (EBRs) and Paper Batch Records• Manages, performs, initiates, or supports change management records, investigations, Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities• Manages projects, leads execution, and participates in projects within Drug Product Finished Goods• Assists and supports inspections and audits, providing support to ensure compliance within the manufacturing environment• Assists Manager with projects and training, as needed• Other duties, as needed
Basic Requirements
* High School Diploma or Equivalent with 9 years of applicable industry experience OR• Bachelor's degree with 5 years of applicable industry experience OR• Master's degree 3 years of applicable industry experience OR• PhD without experience OR• Equivalent Military Experience
Preferred Requirements
* High degree of understanding of operations sequence and cadence of activities in a manufacturing environment
* Bio Works or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Will work in environment which 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 wrists, 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 warm/cold environments
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
Manufacturing technician 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.
• 1. Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements. 2. Must complete training and comply with applicable cGMP requirements. State type and 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.
• 1. Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis.
• 2. Basic understanding of the metric system.
• 3. Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns.
• 4. Must possess mechanical ability to assemble and operate equipment.
• 5. Must pay attention to detail by following procedures and noting unusual conditions.
• 6. Must have written and oral communication to read procedures, write accurate observations and follow directions Position Comments visible to MSP and Supplier: Skills Skills Skills:Category Name Required Experience No items to display.
• 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
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.
• 1. Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis.
• 2. Basic understanding of the metric system.
• 3. Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns.
• 4. Must possess mechanical ability to assemble and operate equipment.
• 5. Must pay attention to detail by following procedures and noting unusual conditions.
Additional Information
Sneha Shrivastava
Technical 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 1, Drug Product
Manufacturing technician job in Holly Springs, NC
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
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, support operational readiness initiatives as well as site commissioning and qualification efforts
• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)
• Owns, performs, or drives documentation major documentation updates (i.e. Initiates new documents for new processes)
• Coordinates non-batch activities (e.g., Changeover, PMs, Aseptic Process Simulation [APS])
• Supports the MSAT group with tech transfer within manufacturing
• Ensures compliance and safety procedures are followed in manufacturing environment
• Create and updates Electronic Batch Records (EBRs) and Paper Batch Records
• Manages, performs, initiates, or supports change management records, investigations, Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities
• Manages projects, leads execution, and participates in projects within Drug Product Finished Goods
• Assists and supports inspections and audits, providing support to ensure compliance within the manufacturing environment
• Assists Manager with projects and training, as needed
• Other duties, as needed
Basic Requirements
• High School Diploma or Equivalent with 9 years of applicable industry experience OR
• Bachelor's degree with 5 years of applicable industry experience OR
• Master's degree 3 years of applicable industry experience OR
• PhD without experience OR
• Equivalent Military Experience
Preferred Requirements
• High degree of understanding of operations sequence and cadence of activities in a manufacturing environment
• Bio Works or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which 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 wrists, 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 warm/cold environments
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-ApplyAssociate III, Downstream Manufacturing
Manufacturing technician 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.
Production Technician - NC #2684
Manufacturing technician job in Garner, NC
Title Production Technician - NC #2684 Worldwide manufacturing company with operations in North Carolina. The strength of the organization is a focus on continuous innovation and investments in both product and technological developments.
. Complies with all company safety rules and procedures.
. Monitors and reacts in a timely manner to routine demand maintenance requirements.
. Participates in routine Preventative/Predictable Maintenance.
. Troubleshoots equipment stoppages and reacts accordingly.
. Utilizes various mechanical and electrical test equipment.
. Assists with manufacturing during product change-over.
. Plans, assists, documents, and implements process improvement techniques and devices.
. Utilizes machining, electrical and mechanical trade skills to complete daily tasks.
. Communicates with production and other various customers as needed.
. Performs other tasks as assigned by management.
. Formal training and practical experience in an industrial setting as a Production Technician.
. Associates degree in applied technology in industrial/manufacturing or equivalent experience
. 3-5 years practical hands on experience in an industrial setting
. Experience with high pressure hydraulics, pneumatics, and automated material handling utilizing 480vac VFD's, and PLC control logic troubleshooting
. Good mechanical aptitude
. Ability to work with minimal supervision on various optimization projects from conception to completion
. Ability to produce technical reports and update drawings
. Light machining and welding skills
. Light fabrication skills
. Good verbal and written communication skills
. Able to interpret and produce mechanical and electrical drawings and schematics
Bottom line requirements we need notes on with candidate submittal:
1. Formal training in an industrial setting as a Production Technician.
2. Associates degree in applied technology in industrial/manufacturing or equivalent experience.
3. 3 + years practical hands on experience in an industrial setting.
4. Experience with high pressure hydraulics, pneumatics, and automated material handling utilizing 480vac VFD's, and PLC control logic troubleshooting.
5. Ability to troubleshoot complex multi-machine production line.
6. Preventative Maintenance, High Speed Manufacturing, and Packaging experience are pluses.
Additional Information
All your information will be kept confidential according to EEO guidelines.