Specialist Computer Systems Validation Engineer
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Specialist Computer Systems Validation Engineer
Live
What you will do
Lets do this. Lets change the world. In this vital role you will join our ARI (Amgen Rhode Island) DTI (Digital Technology & Innovation) (Digital Technology & Innovation) team to help drive productivity through the company by creating opportunities to stop, optimize processes and then implement and automate as appropriate
Responsibilities:
- Serve as a lead with business and DTI partners for process and computer systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, developing, testing, and communicating business cases for proposed solutions, and serving as the lead throughout and post implementation
- Develop an expert-level understanding of the computer systems platforms, processes, and procedures with a strong emphasis on 'As Is' process and systems mapping, 'To Be' visioning, and identifying and articulating business and DTI functional gaps
- Lead computerized system compliance initiatives and be the change and release agent for all computerized system compliance activities on the automation, business and analytical platforms ensuring that platforms carry out to Amgen corporate, GxP and SOX compliance requirements
- Lead computer validation testing initiates with oversight of project resources and analysis of test results and preparation of summaries
- Engage with key vendors and platform owners to understand functionality and how those platforms can be used to tackle compliance or business problems
- Structure and standardize processes that can be used across the various platforms for scalability, efficiency, and growth
- Develops and maintains policies, standards, user guides and guidelines across the platforms
- Ensuring alignment to Amgen and regulatory standards and procedures for computerized systems
- Provide guidance and set standards in producing quality documentation, serving as liaison between DTI and Quality functions
- Data integrity, compliance, and inspection readiness lead for site computer systems platforms
- You are leading from the front engaging with business functions across the company to identify bottlenecks in their business process
- You also will work and collaborate with the DTI system owners and business owners to determine the best solutions for the system to ensure they remain compliant.
- You will be a participant in all phases of the Computerized Systems Lifecycle including, business client expectation and requirement documentation, process and systems analysis, and articulating system solutions and approaches for addressing business needs pertaining to cross-systems integration requirements and design.
- You will also drive strategic multi-functional meetings to facilitate the optimization of systems through implementation of solutions that enable automation to improve or remain in compliant way
- Highlight value of data integrity throughout the business, leading and maintaining compliance for computer systems platforms
The ARI DTI team is part of the Digital Technology and Innovation organization at Amgen that is focused on helping improve staff experience, unlock productivity and improving quality leveraging technology to identify inefficient processes, foster simplification of processes and help automate these revised processes to unlock value. This is a highly visible team with a remit to help shape the future pipeline of Amgen products by unlocking value.
Our customers include Amgen staff and various organizations within functions such as Amgens internal and external digital and quality community across the globe. Our teams are groups of high-energy, motivated doers that want to improve the lives of our partners through continuous productivity improvement via the use of automation, business, and analytical software technologies.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.
Basic Qualifications:Doctorate degreeOr
Masters degree and 3 years of Information Systems or Engineering experience
Or
Bachelors degree and 5 years of Information Systems or Engineering experience
Or
Associate degree and 10 years of Information Systems or Engineering experience
Or
High school diploma / GED and 12 years of Information Systems experience
Preferred Qualifications:
- Strong customer service focus with the demonstrable ability to develop and maintain effective working relationships with team members, partners, and management.
- Demonstrate strong collaboration across all levels of the organization. Aggressive and confident in raising action points with senior individuals with excellent spoken and written communication.
- Experience performing and documenting business processes redesign and aligning business requirements to technical solutions
- Strong verbal and presentation communication skills and ability to engage with varying levels of audience both technical and non-technical
- Experience writing and publishing internal documents, user documentation, and SOPs. Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies
- Strong validation lifecycle Management and Data Integrity experience applying to computer systems (I.e., Business, Automation and Analytical Systems)
- Continuous improvement approach (i.e., LEAN, Kaizen, Six Sigma etc.)
- Experience with SAFe (Scaled Agile Framework) and traditional Agile methodology coupled with strong GxP experience and knowledge on regulations FDA (Food & Drug Administration) Title 21 CFR (Code of Federal Regulations) Part 210 and 211.
- Possess general knowledge of enterprise systems (e.g., Workday, Salesforce, Service Now, SAP)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
-
Specialist Computer Systems Validation Engineer
2 weeks ago
West Greenwich, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Specialist Computer Systems Validation Engineer
2 weeks ago
Greenwich, Ohio, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
West Greenwich, United States National Guard Employment Network Full timeJob 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,...
-
Senior Computer Systems Validation Analyst
2 weeks ago
West Lebanon, United States Novo Nordisk AS Full timeThe purpose of the Senior CSV Analyst position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. The Senior CSV Analyst ensures that IT solutions Validation, Analyst, Computer, Systems, Senior, Operations, Technology
-
Systems Network Engineer
2 months ago
West Chester, United States Computer Systems Resource, Inc. Full timeJob DescriptionJob DescriptionFULL-SERVICE TECHNOLOGY SERVICES PROVIDERAGAIN, IN SEARCH OF MOTIVATED ENGINEERSAfter the events of the last few years, are you professionally better off?We keep growing. A growing company is good place to be. Let's talk. If you are:an experienced system/network engineer, with two years hands-on or help-desk experience, and...
-
Systems Network Engineer
4 weeks ago
West Chester, United States Computer Systems Resource, Inc. Full timeJob DescriptionJob DescriptionFULL-SERVICE TECHNOLOGY SERVICES PROVIDERAGAIN, IN SEARCH OF MOTIVATED ENGINEERSAfter the events of the last few years, are you professionally better off?We keep growing. A growing company is good place to be. Let's talk. If you are:an experienced system/network engineer, with two years hands-on or help-desk experience, and...
-
Validation Engineer
3 weeks ago
West Melbourne, United States Wabtec Full timeWabtec Corporation is a leading global provider of equipment, systems, digital solutions and value-added services for freight and transit rail. Drawing on nearly four centuries of collective experience across Wabtec, GE Transportation and Faiveley Transport, the company has unmatched digital expertise, technological innovation, and world-class manufacturing...
-
Mfg Systems Engineer
23 hours ago
West Greenwich, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Mfg Systems Engineer
21 hours ago
West Greenwich, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Instrument Validation Specialist
4 weeks ago
West Point, United States Kaygen Full timeDescription: This will be within the client's quality control labs in their manufacturing division. Need someone that has worked in GMP/GxP environments, hands-on lab equipment validation experience, and lab/QC system implementation experience. Need someone with strong communication skills so they can work independently with key stakeholders. Role is through...
-
Validation Engineer
1 month ago
West Columbia, United States Nephron Pharmaceuticals Corp Full timeCorporate Statement Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location...
-
Validation Engineer
4 weeks ago
West Columbia, United States Nephron Pharmaceuticals Corp Full timeCorporate Statement Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location...
-
Mfg Systems Engineer
3 days ago
Greenwich, Ohio, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Mfg Systems Engineer
3 days ago
Greenwich, Ohio, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Validation Engineer III
1 month ago
West Chester, United States Teva Pharmaceuticals Full timeWho we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic...
-
Validation Engineer III
2 weeks ago
West Chester, Pennsylvania, United States Tevapharm Full timePress Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Select how often (in days) to receive an alert:West Chester, United States, Pennsylvania, 19380Job Id: 55423Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission...
-
Validation Engineer III
4 weeks ago
West Chester, United States Teva Pharmaceuticals Full timeWho we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic...
-
MES Validation Engineer
1 month ago
West Covina, United States Valspec Full timeJob DescriptionJob DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle...
-
MES Validation Engineer
4 weeks ago
West Covina, United States Valspec Full timeJob DescriptionJob DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle...
-
System Engineer
3 days ago
Greenwich, United States MTK Resources Full timeThis role is at a very well established hedge-fund. Strong Python and Scripting are needed. Job Description: This role entails responsibilities of managing our diverse server infrastructure, networking, VMWare, and other critical business technology solutions. As an integral member of the team, you will collaborate closely with the CTO, Engineering team,...
