Specialist Manufacturing - Deviations Job at Amgen (Juncos)

Specialist Manufacturing: Process Owner, Manufacturing Services

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

Location

United States , Holly Springs

Salary:

107545.40 - 145502.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor's degree and 5 years of biotechnology operations experience or Associate's degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience

Job Responsibility

Manufacturing services technical expert who leads weigh and dispensing operations, media and buffer solution preps and participates in projects, including aiding in commissioning and qualification and training staff on single-use technology, analytical equipment and processes
Coordinating with New Product Introduction (NPI) team, Manufacturing, Process Development, Supply Chain, 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)
Support Manufacturing in troubleshooting, problem solving and participating in deviation RCAs
Own and CAPA and Change Controls to prevent error recurrence and continuous improvement
Ensure that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and align with electronic batch records
Lead tabletop and water runs to test records and SOP updates prior to use before major changes
Provide hypercare support during first batch runs, PPQs, and/or during implementation of new technologies

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Specialist Manufacturing Drug Substance

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Or Master's degree and 2 years of Manufacturing/Quality Support experience
Or Bachelor's degree and 4 years of Manufacturing/Quality Support experience
Or Associate's degree and 8 years of Manufacturing/Quality Support experience
Or High school diploma / GED and 10 years of Manufacturing/Quality Support experience

Job Responsibility

Serve as the subject matter expert for specific manufacturing processes, equipment, systems or deviations & CAPAs management, providing technical leadership across the site
Own and maintain SOPs, batch records, deviations, CAPAs, CAPAs EVs and technical documentation to ensure compliance with cGMP and regulatory standards
Lead troubleshooting efforts for complex process or equipment issues, conducting root cause analyses and implementing preventive measures
Monitor manufacturing data and key performance indicators metrics to identify trends, risks, and opportunities for improvement
Drive continuous improvement by exploring new technologies, digital tools, and best practices to enhance process efficiency and reliability
Provide formal training and mentorship to team members on new or complex manufacturing processes, systems, deviations, and CAPAs/EVs management
Represent Manufacturing in cross-functional meetings, audits, and investigations, translating technical insights into actionable recommendations
Lead or support change controls, deviations, and CAPAs to ensure consistent product quality and regulatory compliance
Plan and manage projects related to process optimization, ensuring timely execution and alignment with quality standards
Support a culture of accountability, safety, and performance by modeling high standards and reinforcing compliance expectations

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental & vision coverage
Life & disability insurance
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

Specialist Manufacturing - Production Process Owner

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States of America , Thousand Oaks

Salary:

107545.40 - 145502.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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

Job Responsibility

Support change control activities to ensure GMP, regulatory, and operational compliance
Evaluate and justify process or equipment changes and assist with project execution
Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations
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, ensuring configuration alignment with process design and GMP requirements
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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Specialist - Manufacturing Investigations

You will be a key member of the team that investigates major deviations in the A...

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience OR Bachelor's degree and 5 years of biotechnology operations experience OR Associate's degree & 10 years of biotechnology operations experience OR High school diploma / GED & 12 years of biotechnology operations experience

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

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Quality Assurance Specialist - Manufacturing Support

Serve as Quality Assurance Specialist responsible for Plant Quality Assurance (P...

Location

United States of America , Holly Springs

Salary:

104287.35 - 141094.65 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Doctorate degree

Job Responsibility

Provide Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports
Oversee and provide guidance during on-the-floor analytical testing
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

Fulltime

Manufacturing Specialist

The Manufacturing Specialist will work with the operation leadership and product...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor’s degree in area(s) of study necessary for the role: Industrial, Mechanical, or Manufacturing Engineering
Engineering Management
or closely related
Minimum 1 year of manufacturing experience
Expertise in Technical Writing: Controlled Documents, Training Materials, Investigations, CAPAs or Similar
Proficient in Good Documentation Processes

Job Responsibility

Assist in the execution of new product development protocols as necessary including engineering runs, media fill, and stability studies
Create new batch records and support documentation
Draft and revise Standard Operating Procedures (SOPs)
Author change controls for process updates
Updating existing batch records for process improvements
Train with the Deviation Management System (DMS) to write investigations
Assist with commercial compounding and filling operations as necessary

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Specialist Manufacturing - DP Production Process Owner

At Amgen, our mission—to serve patients—drives everything we do. As a Specialist...

Location

United States , Thousand Oaks

Salary:

107545.40 - 145502.60 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

Support change control activities to ensure GMP, regulatory, and operational compliance
Evaluate and justify process or equipment changes and assist with project execution
Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations
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, ensuring configuration alignment with process design and GMP requirements
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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Manufacturing Specialist

The Manufacturing specialist acts as primary production process owner and subjec...

Location

United States , Birmingham

Salary:

Not provided

Evonik Industries

Expiration Date

Until further notice

Requirements

BA/BS Degree in STEM subject or combination of education and experience relevant to the position or AA/AS Degree in related subject and 2-4+ years experience relevant to the position
High School Degree in related subject and 4+ years experience relevant to the position
Strong understanding of cGMP, GDP, and regulatory standards (FDA, EMA, etc.)
Experience with cleanroom operations and batch execution
Proven ability to support or lead training programs for manufacturing staff
Familiarity with validation protocols and regulatory expectations
Strong communication and cross-functional collaboration skills
Detail-oriented with a focus on compliance and continuous improvement
Ability to work in a regulated environment with changing priorities
Flexibility to train on day shift and transition to assigned shift schedule as needed

Job Responsibility

Execute cGMP batch manufacturing processes in cleanroom environments
Ensure regulatory compliance (FDA, EMA, IPEC, ISO) within manufacturing operations
Train frontline personnel and support development and maintenance of training materials and curricula
Lead safety, environmental compliance, and housekeeping initiatives in manufacturing areas
Collaborate cross-functionally with internal departments and management on production readiness and process transfer activities
Support CMO readiness and participate in client interactions, including site tours and meetings
Monitor and improve GMP documentation practices, training effectiveness, deviation root cause analysis, and release processes
Ensure adherence to Good Documentation Practices (GDP) and support maintenance shutdowns as needed
Execute validation activities (IOQ, PPQ) with minimal supervision
Identify and implement continuous improvement opportunities in manufacturing systems and processes

What we offer

performance-based remuneration
occupational health benefits
hybrid and flexible working environments
attractive career paths
high-quality development programs

Fulltime

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