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Company

Original Job Post

Amgen · 2 days ago

Specialist Computer Systems Validation Engineer

West Greenwich, RI

Full-time

Hybrid

Mid Level

3+ years exp

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BiotechnologyHealth Care

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Comp. & Benefits

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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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Doctorate DegreeBusiness process redesignTechnical solutions alignmentPublishingKnowledge assimilationValidation lifecycle managementData integrityContinuous improvementLEANKaizenSix SigmaSAFeAgile methodologyGxP experienceEnterprise systems knowledgeCustomer service focusCollaborationCommunicationProblem-solvingAdaptability

Required

Doctorate degree

Master’s degree and 3 years of Information Systems or Engineering experience

Bachelor’s degree and 5 years of Information Systems or Engineering experience

Associate degree and 10 years of Information Systems or Engineering experience

High school diploma / GED and 12 years of Information Systems experience

Preferred

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)

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Group medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements

Company

Amgen

Glassdoor

4.2

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

Founded in 1980

Thousand Oaks, California, USA

10,001+ employees

http://www.amgen.com

H1B Sponsorship

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2023 (349)

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