Manufacturing Specialist Job at Fagron (Wichita)

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Specialist-Manufacturing Investigations

In this vital role, you will be a key member of the team that investigates major...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Quality Control experience
Associate’s degree and 8 years of Quality Control experience
Bachelor’s degree and 4 years of Quality Control experience
Master’s degree and 2 years of Quality Control experience
Doctorate degree

Job Responsibility

Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings
Drive improvements to the investigation process
Present investigations to regulatory inspectors, internal auditors, and management
Clearly communicate investigation progress to impacted areas and leadership
Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule
Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues
Build effective relationships across functions
Navigate through ambiguity and provide a structured problem-solving approach
Apply inductive and deductive reasoning in the investigation process
Clear and concise technical writing

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Specialist Manufacturing: NPI, Upstream Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Contract Manufacturing (CM) Specialist

Location

Malaysia , Johor Bahru

Salary:

Not provided

Cricut

Expiration Date

Until further notice

Requirements

English fluency (written and spoken) is a must
mandarin and/or Malay is a plus
Advanced knowledge on Microsoft Excel, Word & power point. (lookup, Pivot, formula)
Bachelor’s degree in any field.
2-3 years working experience.

Job Responsibility

Assist in managing assigned Contract Manufacturers against Quality, supply & cost objectives throughout the product lifecycle.
Assist in Analyse and benchmark all CM (contract manufacturers) costed BOM submissions VS Internal BOM with assistance from component sourcing managers
Assist on CM Quarterly PPV claim
Responsible for monitoring CM delivery status on a weekly basis.
Responsible for checking all the quotations submitted by CM
PO Issuance
Oversee all day-to-day commercial issues/escalations from CM & internal stakeholders

What we offer

outstanding medical, dental, vision, and retirement benefits
pet insurance
401K match
life insurance
incentive programs
paid time off
on-site massages
phenomenal work-life balance
employee discounts

Fulltime

Specialist Contract Development & Manufacturing

The Specialist Contract Development & Manufacturing at Amgen provides oversight ...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s in Business Administration, Engineering or Science-related field
5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of project management experience leading multi-functional and/or multi-location team
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Job Responsibility

Project Management and Technology transfers: The role involves leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organisations
Follow-up and track activities in a department-wide project from conception to implementation and close-out
Manage timeline and highlight risks of transfer team activities
coordinate risk management activities as part of transfer
provide escalation to the right level
Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting
contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc
Own Deviations (Major/Minor)
Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures
Optimise deviations management, corrective and preventive actions effectiveness to prevent reoccurring events

What we offer

Be part of a global biotechnology leader known for scientific innovation and patient impact
Collaborate with international teams and gain exposure to world-class manufacturing and technology practices
Work in a growth-focused environment with access to professional development programs and cross-functional learning
Hybrid work model and inclusive culture that values well-being, diversity, and work-life balance

Foaming Process Specialist

As a Foaming Process Specialist at BMW Group Plant Debrecen, you play a key role...

Location

Hungary , Debrecen

Salary:

Not provided

BMW

Expiration Date

Until further notice

Requirements

Bachelor's degree in Industrial, Mechanical, Electrical, Mechatronics Engineering or equivalent experience
At least three years of professional experience in production with a good understanding of manufacturing technology
Experience as a foaming specialist in production, ideally in an automated production area
Willingness to work on-site during regular business hours
English and Hungarian communication level language skills
Motivated and creative drive
Assertiveness and initiative
High level of analytical skills and knowledge of problem-solving methods

Job Responsibility

Perform and monitor foaming processes to ensure precise, reliable, and high-quality insulation and structural components
Take responsibility for quality assurance in foaming technology and use destructive and non-destructive testing technologies
Ensure proper preparation and material handling for strong and durable foam applications
Use advanced process technology and adhesive processing techniques for improving efficiency and effectiveness of adhesive applications
Handle glue joint calculations and design considerations
Simulate aging processes and evaluate the long-term performance of foam components

What we offer

Performance-based bonus
Annual cafeteria allowance paid out monthly
Free, direct bus and train services from major cities in the region
Travel cost reimbursement for personal car usage at legally prescribed rate
High-quality healthcare services, physiotherapy, and therapeutic exercise at on-site health center
Private health insurance after probation time
Accident and life insurance
One daily discounted hot meal at company cafeteria
Employee car rental programme

Fulltime

Gluing Process Specialist

As an Gluing Process Specialist at BMW Group Plant Debrecen, you play a key role...

Location

Hungary , Debrecen

Salary:

Not provided

BMW

Expiration Date

Until further notice

Requirements

Bachelor's degree in Industrial, Mechanical, Electrical, Mechatronics Engineering or equivalent experience
At least three years of professional experience in production with a good understanding of manufacturing technology
Experience as an adhesive or gluing specialist in production, ideally in an automated production area
Willingness to work on-site during regular business hours
English and Hungarian communication level language skills
German language knowledge is an advantage
Motivated and have a creative drive as well as assertiveness and initiative
High level of analytical skills and knowledge of problem-solving methods

Job Responsibility

Examination of the adhesive properties of the joined parts
Ensure proper surface pre-treatment for strong and durable adhesive bonds
Take responsibility for quality assurance in adhesive technology and use of destructive and non-destructive testing technologies
Ensure the chosen adhesive meets unique requirements by selecting adhesives from application-specific points of view
Use advanced process technology and adhesive processing techniques for improving efficiency and effectiveness of adhesive applications
Handle glue joint calculations and design considerations
Simulation of aging processes

What we offer

Performance-based bonus
Annual cafeteria allowance paid out monthly
Free, direct bus and train services from major cities in the region
Travel cost reimbursement for personal car usage at the legally prescribed rate
High-quality healthcare services, physiotherapy, and therapeutic exercise option at the on-site health center
Private health insurance after probation time
In work and out of work group accident and life insurance
One daily discounted hot meal at the company cafeteria
Employee car rental programme

Fulltime

Manufacturing Specialist

Fagron

Location:
United States , Wichita

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 16, 2026

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