Biological Product Design Owner Job at Baxter (Braine-l'Alleud)

Solutions Engineer, Life Sciences

At Domino, we build software that helps the largest, AI-driven organizations bui...

Location

United States

Salary:

200000.00 - 250000.00 USD / Year

Domino Data Lab

Expiration Date

Until further notice

Requirements

A technical background in life sciences - you will have worked inside a pharma, biotech, CRO, genomics, or medical device organization doing code-first analytical or scientific work. You understand what it actually feels like to build and run things in that environment.
Working knowledge of at least one life sciences domain - drug discovery, clinical development, computational biology, manufacturing/QC, or regulatory data management. Credible in front of scientific stakeholders without needing to be a domain expert.
Platform or tooling ownership experience - ideally you've built, operated, or meaningfully contributed to an internal platform or shared scientific computing environment. You've influenced or helped shape how that platform served its users, even without a formal product owner title.
Experience in a solutions engineering, pre-sales, or customer-facing technical role - or equivalent internal/consulting work where the job was diagnosing technical problems and helping others solve them, not just executing defined tasks.
You've led or contributed to technical evaluations, pilots, or proof-of-concepts - whether at a vendor, internally, or as a consultant - that drove meaningful adoption or investment decisions.
Demonstrated ability to build: you've written production or near-production code to solve a real scientific or operational problem. Experience creating internal tools, pipelines, or applications for scientific teams is a strong signal.
Proficiency in Python and/or R
hands-on experience with the data science and ML tools used in life sciences technical work. Familiarity with how models get built, validated, and moved toward production in a regulated context is a plus.

Job Responsibility

Engage deeply with the technical problems customers are trying to solve.
Design and run hands-on proof-of-concept projects tailored to each customer's environment.
Work with account executives to design architectures that address life sciences-specific requirements around data governance, reproducibility, and validation (e.g., 21 CFR Part 11, GxP environments).
Proactively identify novel use cases within life sciences customers where Domino could create meaningful value.
Build and maintain reusable technical environments and assets that make future customer engagements faster and more substantive.
Partner with Customer Success and Solutions Architects to make sure customers who complete a POC are set up to succeed in production.
Build custom prototypes and applications on top of Domino for customers.

What we offer

equity
company bonus or sales commissions/bonuses
401(k) plan
medical, dental, and vision benefits
wellness stipends

Fulltime

Engineer (Process Engineering)

Reporting to the Senior Engineer/ Team Lead, this Process Engineer position is p...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Able to work independently with minimal no supervision
Experience in managing various stakeholders' expectations related to process equipment in biopharmaceutical
Good communications skills, both oral and written, including presentation skills
Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities
Ability to combine technical problem-solving skills with business acumen to determine best business solution
Problem solving skills require the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Working knowledge of biopharmaceutical processes such as chromatography, buffer / media tanks, viral filtration, tangential flow filtration, inoculation, bioreactors, harvest, single use technologies and critical utilities is preferred
Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation is preferred

Job Responsibility

Providing operation and New Product Introduction (NPI) support for multiple biologics products and process equipment
Assuming system owner role, taking ownership of various process equipment
Subject matter expert (SME) to ensure equipment operates, functions and performs as intended
Managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions
Developing equipment maintenance program
Presenting equipment qualification and equipment related investigations in all site regulatory inspections
Leading and participating in equipment breakdown investigations
Performing assessment for equipment during new product introduction, change controls and other qualifications activities
Accountable for deviation/change control associated to process equipment performance
Providing technical expertise in site selection assessment

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

What we offer

A 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
Flexible work models where possible

Fulltime

Sr Quality Engineer

As directed by the Quality Engineering Leader, the Quality Engineer II or Sr Qua...

Location

United States , San Diego

Salary:

38.00 - 41.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 3-5 years of experience in Medical Device, Biotech or Pharma Industry
Must have Validation, Nonconformance and CAPA experience
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
Strong verbal and written communication skills
ability to write technical documents
Knowledge of quality system methodologies
Statistical Analysis basic knowledge e.g Minitab or Excel
Strong knowledge of Design Control, Process Validation and Supplier Management
Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)
Hands on experience using Six Sigma methodology

Job Responsibility

Experience with addressing any internal quality issues and help team to resolve it in timely manner with production, quality, and regulatory compliance need
Part of MRB team to help team to create or drive quality notification to release the material
Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities
Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners
Experience performing supplier qualification including Audits and surveys with quality/purchasing/planning team to complete the supplier risk classification and supplier approval list
Support Supplier Corrective Action and Investigation activity to represent the Customer side
Experience on CAPA(Corrective Action and Preventive Action) for internal and external complaints or Non conformance or continuous improvement activities

Fulltime

Specialist Software Development

As a Specialist at Amgen, you will be responsible for developing and maintaining...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
OR Bachelor's degree and 8 - 12 years of Information Science experience
7+ years of direct experience with Biovia OneLab ELN, Thermo Fisher Sample Manager LIMS or comparable ELN solutions
Strong understanding of system ownership responsibilities including: GxP compliance, 21 CFR Part 11 requirements, and validation
System lifecycle management, change control, and audit readiness
Ensuring data integrity and security of scientific records
Proven experience integrating and validating systems within a regulated environment (GxP, FDA, EMA)
Experience with integrating OneLab ELN, LIMS into broader Operations, R&D and IT ecosystems
Familiarity with scientific workflows (biologics, chemistry, lab processes) and ability to translate them into digital solutions
Hands-on technical skills with SQL, Python, AWS, and APIs for data workflows, automation, and system integration

Job Responsibility

Design, develop, and maintain secure, scalable applications and integrations across QC and commercial platforms (AWS, Databricks, Salesforce Marketing Cloud, Mulesoft, LIMS, ELN, and CDS)
Serve as a system owner by managing lifecycle activities (configuration, validation, upgrades, change control, documentation, and audit readiness) in compliance with GxP and 21 CFR Part 11 requirements
Collaborate with business analysts, developers, and stakeholders to gather requirements, deliver validated solutions, and support Agile/DevOps practices
Champion continuous improvement by troubleshooting issues, optimizing workflows, and evaluating new platform capabilities to enhance business value and user experience
Serve as the System Owner for Quality Control Laboratory Platforms (Sample Manager LIMS, Biovia OneLab ELN) ensuring the platform is compliant, validated, secure, and aligned with regulatory requirements
Own the system lifecycle — oversee implementation, upgrades, validation, and retirement activities, following Amgen’s system development life cycle (SDLC) and change management processes
Act as the primary liaison between product team, support team and client facing technology leads
Collaborate closely with developers and technical teams to design, configure, integrate, and validate enhancements, extensions, and interfaces
Lead and coordinate validation activities, including authoring/reviewing test scripts, managing traceability matrices, and supporting audit readiness
Manage integrations and data workflows between OneLab ELN and supporting systems, ensuring seamless interoperability and secure data exchange

What we offer

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

New

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

New

K Kitchen Representative

The position includes, but is not limited to, the following essential job duties...

Location

United States , New Albany

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

K Kitchen Representative

Location

United States , Decatur

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

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Biological Product Design Owner

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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