Associate Scientist, Process Development (Process Validation & Business Strategy) Job at Amgen (Holly Springs)

Specialist IS Analyst

In this vital role, you will work as part of a Product Team focusing on the Elec...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering
Strong experience with enterprise application testing in GxP-regulated environments
Hands-on experience with CSV/CSA validation methodologies and documentation
Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing
Experience supporting enterprise platforms with issue ticketing and customer-facing support models
Proven experience in Application Support & Maintenance (AMS) for regulated systems
Experience with cloud platforms (AWS, Azure, GCP)
Incident response experience, including P1/P2 production incidents
Experience with ServiceNow, ITIL processes, and change management workflows
Ability to translate vendor capabilities and constraints into business-aligned solutions

Job Responsibility

Work as part of a Product Team focusing on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform, accelerating Amgen’s product development and commercial manufacturing
Collaborate with a dynamic, globally distributed team of technical product owners, business analysts, test/validation engineers, project managers, and scrum masters on the design, development, validation, support, and continuous optimization of Amgen Operations’ ELN ecosystem
Possess strong software development skills and rapidly translate concepts into working, production-ready solutions
Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
Create and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operations
Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
Stay current with emerging technologies, industry best practices, and regulated system development trends
Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirements
Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation
Develop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releases

Senior Applied Scientist

As a Senior Applied Scientist, do you enjoy solving problems, looking at problem...

Location

United States , Redmond

Salary:

119800.00 - 234700.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 4+ years related experience (e.g., statistics predictive analytics, research)
Master's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 3+ years related experience (e.g., statistics, predictive analytics, research)
Doctorate in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 1+ year(s) related experience (e.g., statistics, predictive analytics, research)
equivalent experience
Experience with agentic frameworks and orchestration, agentic retrieval/search (multi-step, adaptive re-search) for enterprise environments, and systematic evals using rubrics + quantitative metrics to measure and improve agent quality end-to-end
3+ years experience creating publications (e.g., patents, libraries, peer-reviewed academic papers)
Experience developing AI Agents
Experience presenting at conferences or other events in the outside research/industry community as an invited speaker
3+ years experience conducting research as part of a research program (in academic or industry settings)
1+ year(s) experience developing and deploying live production systems, as part of a product team

Job Responsibility

Bringing the State of the Art to Products
Establishes collaborative relationships with relevant product and business groups inside or outside of Microsoft and provides expertise or technology to create business impact
Takes initiative and drives activities such as technology transfers attempts, standards organizations, filing patents, authoring white papers, developing or maintaining tools/services for internal Microsoft use, or consulting for product or business groups
May publish research to promote receiving new intellectual property for business impact
Brings new technology and approaches into production by applying long-term research efforts to solve immediate product needs
Collaborates with and bridges the gap between researchers (in community across the company, Microsoft Research [MSR], or in their own organizations) and development teams
Begins to negotiate across teams to ensure cutting edge technology is being applied to products in a practical way that meets key business objectives
Develops an understanding of research approaches used across a group or organization to leverage (and not re-invent) solutions
Independently works to create product impact
Identifies approach, and applies, improves, or creates a research-backed solution (e.g., novel, data driven, scalable, extendable) to positively impact a Microsoft product or service

Fulltime

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Risk Manager

We are seeking a highly motivated Model Risk Manager for Amazon’s Payments Risk ...

Location

Colombia , Bogota

Salary:

Not provided

Amazon Pforzheim GmbH

Expiration Date

Until further notice

Requirements

3+ years of risk management experience, including building, testing, implementing, and validating models in financial services technology, payments, merchant/acquiring, audit/consulting, business software, retail, or online services companies (preferably AI/ML models)
Bachelor's degree in Financial Engineering, Financial Mathematics, Mathematics, Statistics, Computer Science, or related field, OR equivalent knowledge gained from relevant experience
Proven ability to manage difficult risk programs across multiple teams, with experience designing and implementing model risk management programs or processes from the ground up
Strong data analysis and technical skills, including knowledge of SQL and Big Data technologies like Hadoop or similar
Excellent written and spoken communication skills, with ability to transform complex risk concepts into clear documentation and influence business decisions across stakeholders
knowledge of data management fundamentals and data storage principles

Job Responsibility

Drive vision and execution of tactical elements of governance and compliance activities for AI and machine learning (ML) risk models
Assist in managing AI/ML risk management processes in alignment with regulatory requirements
Work with stakeholders and team members to ensure requisite activities associated with AI/ML regulatory guidance occur
Work with team members and leadership to prepare content and facilitate key stakeholder and working group meetings
Work with key stakeholders to ensure requisite activities within the enterprise AI/ML Risk Management Standard occur
Work with key stakeholders on identifying heightened risks, controls, and value of prospective Al/ML use cases
Work with Enterprise Architecture and data scientists to create and sustain a comprehensive Al/ML use intake process
Maintain the comprehensive inventory of Al/ML use cases, evidence of review and approval, and associated documentation
Partner with other functions (e.g., Legal, Compliance) on requisite review and effective challenge of new Al/ML use cases
Partner with subject-matter-experts and strategic leaders to ensure execution of requisite control activities as articulated in the enterprise Al/ML strategy

What we offer

Inclusive Team Culture
Mentorship & Career Growth
Work/Life Balance
flexibility as part of our working culture

Senior Associate, Product Management- Card Site Team

Product Management at Capital One is a booming, vibrant craft that requires reim...

Location

United States , McLean, Virginia; Richmond, Virginia; Chicago, Illinois; New York, New York

Salary:

101100.00 - 138400.00 USD / Year

Capital One

Expiration Date

Until further notice

Requirements

Bachelor’s degree or military experience
At least 1 year of product management experience or at least 1 year of experience in product design, agile delivery, business analysis, data science, or software engineering

Job Responsibility

Collaborate with tech teams to build comprehensive acceptance criteria, identifying and elevating any need for additional research to define future feature design
Breakdown business epics into features and further into user stories, driving your team towards lowest effort or Minimal Viable Product (MVP) for a valid feature test
Effectively use hypothesis-driven assessment of data to ensure your product or feature delivers on real business needs
Own and prioritize feature development roadmaps, ensuring all necessary processes and procedures are followed to manage risk
Work autonomously in an agile environment, to conduct research and develop features that utilize new and evolving technology
Collaborate with designers, technologists, data scientists and subject-matter experts to build cutting edge solutions to help customers
Deliver well-managed product platforms for customers by seeking to understand technology trends and architecture strategy
By actively participating in horizontal forums, harness a network of trusted relationships among tech teams, designers, key internal stakeholders and partner teams
Articulate a succinct product roadmap to deliver business value and share with with stakeholders, elevating your team’s results and becoming a product matter expert

What we offer

Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
Comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being

Fulltime

Data Observability Consultant

We are looking for a data observability consultant who will help mature data qua...

Location

India

Salary:

Not provided

Lingaro

Expiration Date

Until further notice

Requirements

Bachelor’s degree in any quantitative discipline
7 to 10 years of experience in implementing off-the-shelf or be-spoke data observability solutions
Proven experience with data observability tools such as Acceldata, BigEye, Soda, Monte Carlo, Anomalo etc. Or experience implementing bespoke observability solutions using Grafana, Prometheus or cloud native services
Proven experience as a Data Quality Consultant, Data Quality Engineer or similar role
Proficiency in SQL and other programming languages such as Python or R
Ability to clearly articulate, influence, and thought partner with senior business leaders
Understanding of modern technology trends and data stacks in data management and governance
Experience in running customer workshops and other collaboration sessions to discover customer priorities, understand current state, and determine maturity/readiness to execute on enterprise Data Management & Governance vision
Familiarity with Azure, or GCP and associated DQ capabilities
Understanding of cloud-based data storage and data pipeline architecture

Job Responsibility

Data Observability Management: Define end-to-end data quality and observability solution including data quality operating model and framework using relevant Data Observability tools
Data Observability: Lead development and deployment of off-the-shelf or be-spoke solutions that monitor data pipelines and databases with help of automated checks and alerts
Data Quality Improvement: Develop and implement reactive, predictive, and preventive strategies to improve the quality of data in the data analytics products and platforms using various methods including data cleansing, data enrichment, data validation, data observability and AI/ML
Collaboration: Collaborate with data engineers, data scientists, and other stakeholders to ensure data quality across all stages of the data lifecycle
Innovation in Data Quality & Observability: Stay abreast of industry trends and emerging technologies. Propose innovative solutions to enhance data observability processes
Liaise with information security teams, and business data stewards, to define priorities and roadmaps for managing and mitigating risks related to data security and data privacy
Drive upskilling and adoption initiatives on data observability within customer organizations
Contribute to balanced score cards as well as data collection and reporting process for data governance councils for monitoring progress and tracking bottlenecks
Identify and define opportunities for automating data quality related processes
Collaborate with other Data Management consultants at Lingaro to identify and create repeatable methodologies and templates for effectively delivering data management and governance services

What we offer

Stable employment
“Office as an option” model
Flexibility regarding working hours and your preferred form of contract
Comprehensive online onboarding program with a “Buddy” from day 1
Cooperation with top-tier engineers and experts
Unlimited access to the Udemy learning platform from day 1
Certificate training programs
Upskilling support
Internal Gallup Certified Strengths Coach to support your growth
Grow as we grow as a company

New

Radiologic Technologist

As our Radiologic Technologist (Rad Tech), you will be pivotal in producing diag...

Location

United States , Phoenix

Salary:

28.10 - 41.80 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Completion of approved American College of Radiology: Radiologic Technologist Program, upon hire
Medical Radiographer: AZ, upon hire
Basic Life Support - CPR, upon hire
Registered Technologist Radiography ARRT, upon hire
Registered Technologist Bone Densitometry, upon hire
Registered Technologist Computed Tomography, upon hire
Registered Technologist Cardio Interventional Radiography, upon hire
Registered Technologist Mammography, upon hire
Registered Technologist Magnetic Resonance Imaging, upon hire
Registered Technologist Nuclear Medicine Technology, upon hire

Job Responsibility

Produce diagnostic images that enable Radiologists to accurately diagnose and manage patient conditions
Perform a variety of imaging examinations, including X-rays, ultrasound, diagnostic fluoroscopy, CT/CAT scans, and MRIs
Actively contribute to a positive patient experience through direct interaction
Utilize good radiation safety practices for patients, self and others
Display competency performing procedures
follow every step for taking an x-ray (two patient identifier, gel in/gel out, etc)
Always produce high quality films
Accurately mark radiographs with R's and L's, supine and upright (if appropriate)
Assure that patient information is clearly visible
Be competent in one or more areas of Diagnostic Radiology (fluoro, portables, OR, Litho, ED/Trauma)

What we offer

$6500 sign on bonus
medical
prescription drug
dental
vision plans
life insurance
paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

New

Vascular Technologist

Perform non-invasive vascular diagnostic examinations to assess blood flow and d...

Location

United States , Chattanooga

Salary:

32.30 - 48.05 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Graduate of an accredited Sonography institution or At least two (2) years experience in Vascular Sonography, upon hire
Basic Life Support - CPR, upon hire
Registered Vascular Specialist, within 12 - months or Registered Vascular Technologist, within 12 - months

Job Responsibility

Perform non-invasive vascular diagnostic examinations to assess blood flow and detect abnormalities in arteries and veins
Prepare patients, operate specialized ultrasound equipment to capture and evaluate high-quality images, and precisely document findings for physician interpretation
Use two patient identifiers
Compare Doctor’s orders to requisition for accuracy
Obtain accurate medical history and fill out appropriate worksheets
Perform clinical assessment and all diagnostic Vascular Sonography examinations including: Carotids, Aorta, AAA, Renal Duplex, Hepatic/Portal, SMA, Celiac, All types of STENTS and Grafts, Arterial and Venous sonography upper and lower, Segmental pressure exams and stress arterial, other tests as determined by the Technical and Medical directors of the lab
Use cognitive sonographic skills to identify and record appropriate anatomical, pathological, and diagnostic images and is able to recognize the significance of all structures visualized and is able to differentiate normal from abnormal and recognize artifacts
Coordinate work schedule with supervisor and front desk to assure workload coverage and that studies are performed in proper order based on whether they are STAT, pending discharge, or held over from the day before

What we offer

Sign on bonus available
Incentive pay for working nights and weekends
Medical, prescription drug, dental, vision plans
Life insurance
Paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
Tuition reimbursement
Retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Associate Scientist, Process Development (Process Validation & Business Strategy)

Amgen

Location:
United States , Holly Springs

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 08, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Associate Scientist, Process Development (Process Validation & Business Strategy)

Specialist IS Analyst

Senior Applied Scientist

Sterility Assurance Scientist

Risk Manager

Senior Associate, Product Management- Card Site Team

Data Observability Consultant

Radiologic Technologist

Vascular Technologist

Associate Scientist, Process Development (Process Validation & Business Strategy)

Amgen

Location:United States , Holly Springs

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:January 08, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Associate Scientist, Process Development (Process Validation & Business Strategy)

Specialist IS Analyst

Senior Applied Scientist

Sterility Assurance Scientist

Risk Manager

Senior Associate, Product Management- Card Site Team

Data Observability Consultant

Radiologic Technologist

Vascular Technologist

Location:
United States , Holly Springs

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
January 08, 2026