Specialist Computer Systems Validation Engineer
2 weeks ago
HOW 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 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
Let’s do this. Let’s 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
A day in the life :
-
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
About the Team :
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 Amgen’s 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 degree
Or
Master’s degree and 3 years of Information Systems or Engineering experience
Or
Bachelor’s 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 SOP’s. 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)
Thrive
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
Apply now
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
3 months 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 months 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...
-
Validation Specialist
2 days ago
West Melbourne, Florida, United States Wabtec Full timeAbout Wabtec CorporationWabtec Corporation is a leading global provider of equipment, systems, digital solutions, and value-added services for freight and transit rail. With a rich history spanning nearly four centuries, the company has unmatched digital expertise, technological innovation, and world-class manufacturing and services, enabling the...
-
Validation Specialist
1 week ago
West Melbourne, Florida, United States Wabtec Full timeJob Title: Validation SpecialistAbout Wabtec CorporationWabtec Corporation is a leading global provider of equipment, systems, digital solutions, and value-added services for the rail industry. With a rich legacy of experience spanning multiple companies, Wabtec brings unparalleled digital expertise, technological innovation, and top-notch manufacturing and...
-
Validation Engineer
3 months 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...
-
Computer Support Specialist
1 week ago
West Palm Beach, Florida, United States Business & Residential Computer Sys Full timeJob OverviewWe are seeking a skilled Computer Support Specialist with a minimum of A+ certification and experience in Mac OS. This role is essential for providing top-notch technical assistance to our clients.Key Responsibilities:The successful candidate will be expected to:Demonstrate reliability, trustworthiness, and punctuality in all tasks.Utilize prior...
-
Process Engineering Specialist
2 weeks ago
West Greenwich, Rhode Island, United States Innova Solutions Full timePosition Overview:Innova Solutions is seeking a dedicated Process Engineering Specialist to join our team. This role is essential for ensuring the efficiency and reliability of our manufacturing processes.Position Type:Full-time; Contract Duration: 12+ MonthsLocation:West Greenwich, RICompensation:$45 - $48/hr on W2Key Responsibilities:As a Process...
-
MES Validation Engineer
3 months 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...
-
Sustainable Energy Systems Engineer
2 weeks ago
West Palm Beach, Florida, United States Apex Systems Full timeJob#: Job Description: Job Title: AI Innovation Engineer Location: Hybrid Rate: $40-$45/hr Duration: 1 year Contract with opportunity to convert to permanent Overview: The individual in this position will be responsible for analyzing, organizing, executing, and coordinating various assignments. This role requires an exploration of the subject matter,...
-
Specialist, Systems Engineer
3 hours ago
West Valley City, United States L3Harris Technologies Full timeJob Title: Specialist, Systems Engineer Job Code: 15806 Job Location: Salt Lake City, UT Job Schedule: 9/80, off every other Friday Job Description: The System Engineer – Test position owns the test process, including concept, design, root cause analysis, and corrective action. This Engineer will become a subject matter expert via collaboration...
-
Sr Automation Engineer
3 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...
-
Engineer Senior
4 weeks ago
West Greenwich, United States The Judge Group Full timeThis engineering position supports manufacturing activities associated with manufacturing process equipment at Rhode Island (RI). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment. The Engineer role will provide...
-
Sr Automation Engineer
3 weeks 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...
-
Process Engineering Specialist
2 weeks ago
Greenwich, Ohio, United States Innova Solutions Full timeInnova Solutions is actively seeking a Process Engineering Specialist. Position Type: Full-time; ContractDuration: 12+ MonthsLocation: RemoteCompensation: $45 - $48/hr on W2As a Process Engineering Specialist, your responsibilities will include: Key Responsibilities:Possessing a degree in engineering (mechanical or chemical preferred).Functioning as the sole...
-
Computer Systems Analyst I
2 weeks ago
West Point, United States Saalex Full timeWe are seeking a dedicated and detail-oriented Computer System Analyst to join our dynamic team. The successful candidate will be pivotal in optimizing our computing systems, ensuring efficient data distribution, and creating effective scenario files for live operations. If you have a knack for mathematics, precision, and time management, we encourage you to...
-
Senior Systems Engineering Specialist
2 weeks ago
West Mifflin, Pennsylvania, United States Navarro Inc. Full timeJob OverviewNavarro Research and Engineering is seeking a Senior Systems Engineering Specialist to join our dynamic team. This role is integral to our commitment to advancing clean energy solutions and addressing complex challenges in the nuclear and environmental sectors. Our organization is recognized for its dedication to quality and safety, and we are...
-
Process Engineer
3 months ago
West Greenwich, United States ACL Digital Full timeJob Title: Process EngineerLocation: West Greenwich, RIDuration:12 MonthsDescription:Fully onsite in Rhode IslandTop 3 Must Have Skill Sets: Must Haves:1. 4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry2. Local to Amgen Rhode Island3. No work gap more than 3 months4. Demonstrated ability to work independently...
-
Manufacturing Engineer
1 month ago
West Greenwich, United States ACL Digital Full timeTitle: Senior Engineer Location: West Greenwich, RIDuration: 12 months The Engineer role will provide direct engineering technical support as follows:• Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment systems. This may include development of reason for improvement and identification of design...
-
Manufacturing Engineer
4 weeks ago
West Greenwich, United States ACL Digital Full timeTitle: Senior Engineer Location: West Greenwich, RIDuration: 12 months Top Skills:Must have engineering degree (mechanical/ chemical engineering)Must have experience with process equipment in pharma background, will be owning processing manufacturing equip (4-6 years of experience, not less than 4)Must have experience with troubleshooting equipment /...
-
Engineer Senior
4 weeks ago
West Greenwich, United States US Tech Solutions, Inc. Full timeMust have engineering degree (mechanical/ chemical engineering)Will be Single support person, must be self driven and perform independently as will work with cross functional teams outside of campus and they will be supervised remotelyMust have experience with process equipment in pharma background, will be owning processing manufacturing equip (4-6 years of...