Senior Associate Manufacturing

Senior Manufacturing Associate – Single Use Systems (SUS)

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

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED and 4 years of manufacturing or operations work experience
Associate’s Degree and 2 years of manufacturing or operations work experience
Bachelor’s Degree and 6 months of manufacturing or operations work experience
Master’s Degree
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

Job Responsibility

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 offer

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

Fulltime

Operational Excellence Manager

The Operational Excellence Manager is responsible for leading and implementing c...

Location

United States , Rogers

Salary:

Not provided

Kennametal

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Engineering, or related field required
3-5 years demonstrated success in manufacturing and/or supply chain experience plus lean training
equivalent experience in Lean Manufacturing role may be considered in lieu of degree
Knowledge and practice experience of the following tools: Strong leadership skills including communication, teaching and coaching skills
Financial Acumen
Data analyzation, platforms, data modeling and visualization
Advanced in Excel, PowerBI, Project Management tools
5S & Zoning, visual management
Standard work and cycle time measurement
Muda Hunting

Job Responsibility

Lead and implement continuous improvement initiatives
Analyze existing processes, identify areas for improvement, and lead kaizen activities to optimize operations and increase efficiency
Develop competencies of all appropriate people of the Site / Plant about : 5S & Product respect, Reduction of equipment losses, Direct Labor efficiency, Scrap reduction, WIP reduction, Lean industrialization, VSM, To become autonomous in continuous improvement management
Manage site OpEx engineer if needed
Propose to the Site / Plant Manager the internal lean strategy of the Site / Plant
Ensure that the lean rules are taken into account in new projects during validation of each phase
Help Site / Plant Manager to manage continuous improvement
Monitor the whole lean initiative deployment
Manage the production productivity improvement roadmaps
Deploy lean standards & best practices within the Site / Plant

Fulltime

Senior Staff Product Quality Engineer

As a Senior Staff Product Quality Engineer at Boston Dynamics, you will join our...

Location

United States , Waltham

Salary:

114195.00 - 157108.00 USD / Year

Boston Dynamics

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Electrical, Industrial Engineering or other Engineering discipline
6+ years of progressively responsible experience in manufacturing, quality assurance or engineering, including project leadership in high-tech environments
Experience in high-tech manufacturing environments where a wide range of components including PCBAs, electronics, precision machined parts, castings, injection molded plastic parts, optics, and actuators are assembled
Ability to read and interpret engineering drawings and convert them into the quality control plans
Ability to execute product and process qualifications
Experience understanding product issues and how to adequately get them resolved
Experience with creating and approving change orders associated with product, procedures and BOM
Excellent written and verbal communication skills, with experience presenting technical content to engineering, regulatory, and executive stakeholders
Able to translate complex quality data into actionable insights that influence product and process decisions

Job Responsibility

Lead and execute the product quality function throughout the product development and new product introduction (NPI) process
Lead resolution of product quality issues at all stages of the product lifecycle, from prototype to sustaining and across multiple disciplines of the business (including design, supply chain, production and service)
Lead root cause, corrective action and preventive action investigations cross functionally
Collaborate with Design Engineers, Supplier Quality Engineers, Test Engineers and the Operations Team to ensure that quality standards are met
Lead, measure and identify opportunities for improvement in first pass yield (FPY) and other key performance indicators (KPIs)
Plan and lead process qualifications generating clear and concise plans and reports as a result of new product releases and sustaining change
Ensure processes implemented adhere to quality requirements and risks are identified and communicated where nonconformances exist
Provide support to the MRB process to ensure effective root cause/corrective action and prompt and accurate disposition for nonconforming material
Implement methods to inspect and evaluate the reliability of manufacturing processes, products and production equipment. Continually improve these methods through data analysis and business needs
Support and lead audits (internal, customer, third party) to help improve our Quality Management System, as necessary

What we offer

medical, dental vision, 401(k), paid time off and a annual bonus structure

Fulltime

Manufacturing Ops Leader

Lead and oversee daily operations, leads and associates performing resin product...

Location

United States , Perrysburg

Salary:

Not provided

Formlabs GmbH

Expiration Date

Until further notice

Requirements

Degree in engineering, operations, or a related discipline
Minimum 5 years of experience in a senior production/manufacturing role
Proven track record in implementing cultural and operational change initiatives
Experience with lean management practices and continuous improvement projects
Strong interpersonal and leadership skills, with the ability to mentor and develop employees across all levels of the organization
Experience with automation equipment and operational enterprise systems (MES, ERP, QMS, etc)

Job Responsibility

Lead and oversee daily operations, leads and associates performing resin production, fulfillment, and logistics activities
Actively drive and exemplify a strong culture of operational excellence, safety, quality, and continuous improvement
Ownership of and accountability for operations goals, metrics, and initiatives
Monitor and control costs to ensure adherence to budget targets and overall financial efficiency
Develop and implement profit-driven, long-term site strategies with a focus on risk mitigation, innovation, and continuous improvement initiatives
Foster the growth and development of employees and their skills to meet evolving site and business requirements in line with the company’s expansion goals
Utilize lean management tools to achieve sustainable and continuous improvement
Collaborate with R&D, QC, and Engineering teams to align manufacturing plans and resource requirements with business objectives and ensure adherence to quality standards
Work closely with Supply Chain, Fulfillment, Procurement, and Finance teams to optimize production planning, inventory, and on-time delivery of high-quality products to customers
Interface with company leadership to report site performance, discuss roadmap projects, and resolve any site needs requiring leadership or Headquarters intervention

What we offer

Medical, Dental, Vision
3% match of yearly salary for 401(k)
EAP Program
In-office catering 3x per week
120 hours of PTO per year

Fulltime

New

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

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years manufacturing and operations experience OR Associate's + 2 years manufacturing and operations experience OR Bachelor's + 6 months manufacturing and operations experience Master's
Degree in Engineering or Life Sciences
3 years or more 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
Experience leading and managing projects
Understanding of single-use technologies

Job Responsibility

Support manufacturing by providing subject-matter expertise for drug substance downstream processes as Single-use SME
Resolve quick issues and implement function tests to troubleshoot and optimize process
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
Own Quality Records, such as CCMS, CAPA, and CAPA-EV
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
Demonstrate strategic problem-solving skills and champion continual improvement
Ability to be on-site (flexible worker)
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills

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

Fulltime

Senior Manufacturing Engineer - Fabrication

We are looking for a Manufacturing Engineer III to support our team on-site in E...

Location

United States , Eagle

Salary:

Not provided

Energy Systems

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Mechanical Engineering, Industrial Engineering or equivalent technical degree
5+ years related experience in the Engineering function within a similar working environment
10+ years experience in Manufacturing Engineering function directly supporting soft tooled sheet metal fabrication processes, specifically turret punching, laser cutting, press brakes, MIG welding
Manufacturing Engineering experience with Amada and Salvagnini fabrication equipment
Experienced project manager in the acquisition and implementation of new machine tools from start-up to reaching the desired production throughput
Experience with CAD/CAM software associated with sheet metal fabrication equipment
Proficiency in CAD (AutoCAD, Solid Works and/or ProE)
Excellent organizational, written and oral communication skills
Knowledge of lean principles and process improvements
Diverse skills and experience leading projects

Job Responsibility

Significant responsibility for area layouts, process definition, design/selection, justification, and implementation of equipment, programs, and tooling in support of capacity and continuous improvement projects
Responsible for supporting the successful inclusion of Design for Manufacturability (DFM) in New Product Introductions (NPI) that have sheet metal components
Contribute to facility transformation, technology transfer and ongoing maintenance of sheet metal fabrication value streams
Ensure ongoing success of process improvement initiatives by implementing policies, procedures and process documentation that support sheet metal fabrication
Implement demand driven principles and strategies that supports operational excellence and long range plans (Flexibility, Speed & Responsiveness)
Ensure product, material, and information streams flow and are synchronized to produce maximum efficiencies and lowest cost of operation in the sheet metal fabrication areas
Contribute to creation of innovative ideas to improve business results, specifically in the sheet metal fabrication areas
Deploy standard Generac tools, methodologies, standards, practices and processes
Implement objectives to include continuous improvement initiatives to achieve customer satisfaction and fulfillment needs
Work closely with shop floor personnel to promote ongoing Continuous Improvement of manufacturing methods, systems and controls.

Fulltime

Senior Manufacturing Manager - Downstream

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional y...

Location

United States , Holly Springs

Salary:

136227.80 - 184308.20 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Manufacturing & Operations experience
Master's degree and 6 years of Manufacturing & Operations experience
Bachelor's degree and 8 years of Manufacturing & Operations experience
Associate's degree and 10 years of Manufacturing & Operations experience
High School diploma/GED and 12 years of Manufacturing & Operations experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Develop and retain a diverse and high performing team in alignment with operational readiness schedules to ensure successful startup and commercial GMP operations
Mature the site's safety and quality culture of the department and champion continued improvement
Collaborate as one team of all manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners)
Provide support to troubleshoot, identify, and resolve issues as needed and manage call coverage for 24/7 operation
Provide technical leadership for the investigation of deviations and the development of corrective actions
Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement
Lead and support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections
Deliver against organizational financial commitments while championing a lean philosophy

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Specialist, Quality Assurance

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Suppl...

Location

United States

Salary:

149651.00 - 168146.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of Quality Compliance experience
Master’s degree & 4 years of Quality Compliance experience
Bachelor’s degree & 6 years of Quality Compliance experience
Associate’s degree & 10 years of Quality Compliance experience
High school diploma / GED & 12 years of Quality Compliance experience
Bachelor’s degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management

Job Responsibility

Own and lead the SQM/GSQ inspection readiness processes
Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
Maintain and continuously improve inspection readiness processes
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

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

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Senior Associate Manufacturing - Continuous Improvement Lead

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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