National Guard Employment Network
Engineer Physical Methods - Thousand Oaks, CA
National Guard Employment Network, Newbury Park, California, United States, 91320
Engineer Physical Methods - Thousand Oaks, CA
Job Description 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. Let's do this! Let's change the world! The Engineer, in Physical Methods, is responsible for engineering activities required for the development/qualification/validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling, or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support. Responsibilities
Develop, qualify, validate, and transfer GMP physical test methods for vials, prefilled syringes, and injection devices. Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements. Develop, qualify, validate, and transfer new equipment, software, systems, and operational processes. Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget. Provide experienced support for investigations as well as new process development required to improve manufacturing operations. Coordinate test method development and delivery with selected contractors. Ensure that qualification parameters are met for product assembly requirements. Support development of cost estimates for new processes, gauges, and equipment development used in the generation of capital request documentation. Generate procedures necessary to support department and new process equipment. Provide experienced training to individuals in the operation and maintenance of processes, test methods, and equipment introduced to Quality Control and/or the manufacturing department. Participate in and assume responsibilities of team functions as assigned. Generate/author and be responsible for the Test Method documents. Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design. Perform other duties as required by the Group Manager. Align with the requirements, responsibilities, and authority as required. Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work. Network internally to ensure alignment, commitment to project objectives and timelines, as well as to ensure effective execution of projects. Network with manufacturing, quality, and regulatory organizations both internal and external to Amgen. Drive multi-functional communication and integrate information to optimize decision making, issue resolution, and change management throughout the project lifecycle. Demonstrate excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership. Collaborate with other functional leaders to ensure project success, momentum, and commitment. Proactively identify issues and/or risks and implement solutions that resolve issues or increase efficiency. Integrate partner/vendor timelines with Amgen timelines as appropriate. The position may require approximately 10% travel to international locations assisting our development partners, suppliers, and/or Amgen sites to support implementation of physical methods and associated equipment. Minimum Education Required
High School/GED Job Category
Management Additional Qualifications/Responsibilities
What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: High school diploma / GED and 8 years of engineering/scientific experience OR Associate's degree and 6 years of engineering/scientific experience OR Bachelor's degree and 2 years of engineering/scientific experience OR Master's degree Preferred Qualifications: M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry Excellent written and verbal communication skills Ability to work in a highly matrixed team environment 2 years of experience in the biotechnology/pharmaceutical industry 2 years of experience in equipment, method, and mechanical design Technical writing experience Experience with SolidWorks (or other 3D-CAD software) Experience with combination products and regulatory requirements Experience applying Minitab (or other statistical software packages) 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, including remote and hybrid work arrangements, where possible Location
City: Thousand Oaks State: California Job Code
Pharmaceutical Pharmaceutical Company
Amgen
Job Description 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. Let's do this! Let's change the world! The Engineer, in Physical Methods, is responsible for engineering activities required for the development/qualification/validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling, or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support. Responsibilities
Develop, qualify, validate, and transfer GMP physical test methods for vials, prefilled syringes, and injection devices. Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements. Develop, qualify, validate, and transfer new equipment, software, systems, and operational processes. Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget. Provide experienced support for investigations as well as new process development required to improve manufacturing operations. Coordinate test method development and delivery with selected contractors. Ensure that qualification parameters are met for product assembly requirements. Support development of cost estimates for new processes, gauges, and equipment development used in the generation of capital request documentation. Generate procedures necessary to support department and new process equipment. Provide experienced training to individuals in the operation and maintenance of processes, test methods, and equipment introduced to Quality Control and/or the manufacturing department. Participate in and assume responsibilities of team functions as assigned. Generate/author and be responsible for the Test Method documents. Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design. Perform other duties as required by the Group Manager. Align with the requirements, responsibilities, and authority as required. Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work. Network internally to ensure alignment, commitment to project objectives and timelines, as well as to ensure effective execution of projects. Network with manufacturing, quality, and regulatory organizations both internal and external to Amgen. Drive multi-functional communication and integrate information to optimize decision making, issue resolution, and change management throughout the project lifecycle. Demonstrate excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership. Collaborate with other functional leaders to ensure project success, momentum, and commitment. Proactively identify issues and/or risks and implement solutions that resolve issues or increase efficiency. Integrate partner/vendor timelines with Amgen timelines as appropriate. The position may require approximately 10% travel to international locations assisting our development partners, suppliers, and/or Amgen sites to support implementation of physical methods and associated equipment. Minimum Education Required
High School/GED Job Category
Management Additional Qualifications/Responsibilities
What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: High school diploma / GED and 8 years of engineering/scientific experience OR Associate's degree and 6 years of engineering/scientific experience OR Bachelor's degree and 2 years of engineering/scientific experience OR Master's degree Preferred Qualifications: M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry Excellent written and verbal communication skills Ability to work in a highly matrixed team environment 2 years of experience in the biotechnology/pharmaceutical industry 2 years of experience in equipment, method, and mechanical design Technical writing experience Experience with SolidWorks (or other 3D-CAD software) Experience with combination products and regulatory requirements Experience applying Minitab (or other statistical software packages) 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, including remote and hybrid work arrangements, where possible Location
City: Thousand Oaks State: California Job Code
Pharmaceutical Pharmaceutical Company
Amgen