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

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 - Discovery Big Bets

This person will serve as an internal consultant/strategist, dedicated to explor...

Location

United States , New York; McLean; Richmond

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

Proactively seek out and investigate new, large-scale opportunities that have the potential to drive significant future growth for Capital One Travel
Conduct market analysis, competitive landscape assessments, and customer research to fully understand the viability of new spaces
Balance business opportunities with deep customer needs, ensuring that new product concepts solve real problems for the user
Function as an internal consultant and gaining buy-in by effectively communicating the customer value and business potential to core product and delivery teams, who are responsible for the final execution
Take ownership of an idea and building the strategic and evidential case required to turn 'something out of nothing'
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

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

Customer Solution Centre - Technical

Customer Solution Centers are made up of teams that provide remote (offsite) ser...

Location

New Zealand , Auckland

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

First Level University degree: a) technical, b) non-technical (i.e., Bachelor of Arts/ Science). Typically 3-4 year completion beyond High School level, BA/BS or equivalent experience
5-7 years experience in relevant technologies and customer environments
Relevant industry qualification where applicable
Excellent verbal and written communication skills in language to be supported
Advanced troubleshooting skills in a technical environment
Excellent analytical and problem solving skills
Advanced Software and hardware knowledge of computing, storage and peripheral devices
Specific knowledge and training with the company's products. Knowledge of multiple product lines (for example, proactive, reactive, storage, enterprise systems, tier 2 or 3 support, etc.)
Advanced proficiency with case management databases and tools
Superior customer service skills

Job Responsibility

Successfully resolve technical issues (hardware and software) from incoming internal or external businesses and end user's contacts and proactive notification systems
Respond to service, product, technical, and customer- relations questions on subjects such as features, specifications, and repairs on current and discontinued products, parts, and options, based on customer entitlement (warranty through mission- critical)
Proactively assist internal or external businesses and end users to avoid or reduce problem occurrence
Ability to act as a mentor and guide other employees. Ability to provide direction and guidance to process improvements
Ability to articulate clearly, recommend and explain resolutions /clients
Understand and utilize ITIL
Represent the company in a face to face customer location visit, industry conference/trade show, vendor meeting, etc.

What we offer

Health & Wellbeing
Personal & Professional Development
Unconditional Inclusion

New

Administrative Assistant

We are looking for a detail-oriented Administrative Assistant to join our team i...

Location

United States , Brooklyn, New York

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in administrative assistance or a similar role
Strong proficiency in data entry and record-keeping
Excellent communication skills, both verbal and written
Familiarity with office software, including word processing and spreadsheet tools
Ability to multitask and manage time effectively in a dynamic environment
Attentive to detail and customer service skills
High attention to detail and organizational abilities

Job Responsibility

Manage and organize administrative tasks to ensure smooth office operations
Answer and direct inbound calls promptly and professionally
Maintain accurate records and perform data entry with precision
Support daily office functions, including filing, scheduling, and correspondence
Serve as the first point of contact for visitors and clients, providing excellent reception services
Collaborate with team members to ensure timely completion of projects and assignments
Coordinate meetings and appointments, ensuring proper documentation and communication
Assist in preparing reports, presentations, and other business documents as needed

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

New

Visual Designer

The Visual Designer will be responsible for the creation of visually innovative ...

Location

United States , Atlanta

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

A bachelor’s degree in visual/graphic design/brand communication (or a related field)
5+ years of experience designing cross-platform visual systems, particularly, mobile (iOS, Android) and web other devices
packaging and print work a plus
Experience creating brand guidelines and style guides
The experience and ability to lead the visual aspects of a project
Impressive skills in visual storytelling, ideation and sketching, visual interface design, data visualization and motion graphics and an affinity for HCI/interaction design and prototyping
An incurable curiosity relating to all things design and technology and a willingness to share your knowledge
Excellent communication and presentation skills and have desire to share what you know

Job Responsibility

Creation of visually innovative and engaging products
Creating visuals for mobile, web, and tablet
Use design to bring product ideas to life

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

New

Senior Customer Service Advocate

Sr Customer Service Advocate. This role has been designed as ‘Onsite’ with an ex...

Location

India , Chennai

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Typically a Bachelor's degree or equivalent experience and 4-6 years related experience or Master's degree and 2-4 years experience
4-6 years related experience in a telephone support position in a service or end-user support environment
2 years experience in the microcomputer industry
Technical training in the company or other manufacturers' product lines
Working knowledge of the field of Customer Relations
Excellent verbal communication and customer service skills
Intermediate-level knowledge of operating systems software
Demonstrated writing/correspondence skills
Experience and demonstrated presentation skills
Knowledge of legal ramifications/conflicts in Customer Relations environment such as consumer rights and manufacturers' warranty responsibility

What we offer

Health & Wellbeing benefits
Personal & Professional Development programs
Unconditional Inclusion environment

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

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