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

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

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

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

New

Staff Software Engineer

The Staff Software Engineer on the Engineering team is responsible for the imple...

Location

India , Pune

Salary:

Not provided

LogicMonitor

Expiration Date

Until further notice

Requirements

8+ years of software development experience in commercial or enterprise applications
6+ years of full-time experience as a Java developer on Linux platform
BS or above degree in computer science or related field
Expertise with latest Java development framework and open-source tools
Extensive experience and knowledge with inner workings of JVM
Strong understanding of web application architectures, specifically Apache Tomcat
Experience in SaaS Product Development dealing with large volumes of data
Deep SQL / NoSQL database knowledge, including following databases: MySQL, Cassandra, and ElasticSearch
Extensive experience with one of the following Big Data technologies: Apache Spark, Kafka Streams, AWS Kinesis/Firehose
Experience designing large, complex distributed systems

Job Responsibility

Prioritize and plan for deliverables in an iterative development strategy, according to our 2 week scrum schedule & 1 week regression testing
Design, document, code, and test technical solution for new systems or enhancements to existing systems
Follow agile software development methodologies for implementation
Working with various teams in LogicMonitor to deliver software products that support LogicMonitor's business growth
Provides technical leadership mentoring and guidance at senior engineering levels and below
Trusted to represent the team to other functional teams
Coordination, Communication, and Collaboration between management, product, techops, support, developers
Envision system features and functionalities by analyzing business requirements
Troubleshoot and resolve product/application issues for escalated support cases
Collaborate with a diverse, distributed development organization

Fulltime

New

Account executive strategic enterprise

LogicMonitor® is the AI-first hybrid observability platform powering the next ge...

Location

United States , Seattle

Salary:

116380.50 - 155000.00 USD / Year

LogicMonitor

Expiration Date

May 11, 2026

Requirements

8+ years of experience in B2B technology sales
Proven ability to exceed $1M+ ARR sales quotas in SaaS or equivalent for non-SaaS
Exceptional communication skills, with the ability to simplify and articulate complex technologies
Strong executive relationship-building, with experience engaging and influencing C-level stakeholders
Demonstrated success in both net new customer acquisition and existing account expansion
Familiarity with the MEDDPICC sales methodology is preferred

Job Responsibility

Engage & Understand Customer Needs: Build relationships with IT personnel and key stakeholders to uncover business challenges and objectives
Solution-Based Selling: Apply a consultative sales approach to deliver tailored, value-driven IT performance monitoring and SaaS enterprise solutions
Manage Sales Cycles: Identify and close opportunities across both short and complex sales cycles, ensuring strategic prioritization and appropriate resource allocation
Drive Growth & Expansion: Secure new business while expanding existing accounts
Optimize Sales Execution: Effectively allocate resources and align internal teams to support sales efforts and customer success
Maintain CRM Accuracy: Keep detailed records in Salesforce, tracking customer interactions, use cases, timelines, success criteria, red flags, and potential risks
Exceed Targets: Consistently achieve and surpass pipeline and revenue goals

What we offer

Comprehensive health, dental and vision coverage
generous parental leave policies
access to our Employee Assistance Program and various Wellness programs
a 401K with company matching
a Lifestyle Spending Account
unlimited vacation policy

Fulltime

New

Senior Field Service Engineer

The purpose of this role is to secure the functional efficiency of the filling m...

Location

Salary:

Not provided

SIG Group

Expiration Date

Until further notice

Requirements

5+ Experience in the aseptic industry and/or food strongly preferred
Proven record in Field Service and customer contact
Proficiency in written & Verbal English and French is a must
Local Language is Required

Job Responsibility

Secure the functional efficiency of the filling machine lines at customer site
Consider the commercial conditions required while performing service and maintenance duties
Demonstrate advanced knowledge & understanding how related items work
Lead inspections, repairs, preventive maintenances or trouble-shooting at customer site
Preparation of technical reports and record any customer complaints
Support & Coaching of the FSE’s & customer staff regarding technical problems and machine operating best practices
Recommendation & ordering of spare parts when required with customer approval
Installation of modifications when required
Leading of the personnel at the site when required
As required installation of filling line

What we offer

Competitive compensation
Opportunity to partially work from home
Part of a globally successful international company
Personal development opportunities
Trainings and coaching opportunities from senior team members

New

Environmental, Social, and Governance Support

Working as Full-time Environmental, Social, and Governance Support, you will wor...

Location

United States , Winona

Salary:

35000.00 - 40000.00 USD / Year

Fastenal

Expiration Date

March 30, 2026

Requirements

Excellent written and oral communication skills
Proficient using Microsoft Office Suite
Exhibit strong problem solving, deductive reasoning and decision making skills
Demonstrate strong organization, planning and prioritizing abilities
Demonstrate strong math aptitude, attention to detail and sense of urgency
Learn and perform multiple tasks in a fast paced environment
Work independently as well as in a team environment
Demonstrate our core values of ambition, innovation, integrity and teamwork
Willingness to work a flexible schedule
Pass the required drug screen (applicable in the US, Puerto Rico and Guam ONLY)

Job Responsibility

Maintaining various aspects of the organization's Environmental, Social, and Governance (ESG) and corporate social responsibility (CSR) program
Monitoring key aspects of Fastenal's CSR and ESG policies, programs, practices, training and goals
Assisting with the development of relationships with community organizations where Fastenal maintains significant operations
Establishing, measuring and reporting on data based Key Performance Indicators to guide the company's CSR and ESG improvement efforts
Assisting with the engagement of relevant internal stakeholders to strengthen Fastenal's commitments and disclosures
Assisting with the development of documentation for external CSR/ESG stakeholders, including large customers, investors and CSR industry influencers that build Fastenal's reputation
Researching and preparing data responses addressing external stakeholder's inquiries, questionnaires and audits
Assisting with the management of Fastenal's submissions and scores with key CSR and ESG influencers, such as CDP, SASB, EcoVadis, etc.

What we offer

Health, Life, Long Term Disability, and Dental Insurance
paid vacation
sick leave
holidays
401(k) with an employer contribution
bonus and/or commission eligibility

Fulltime

New

Quality Manager

The Quality Manager oversees and ensures the consistent quality of products and ...

Location

United States

Salary:

100000.00 - 125000.00 USD / Year

SIG Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher required
Preferred fields of study include Engineering (Chemical, Food, Production/Manufacturing) or Chemistry (Chemical or Industrial)
Postgraduate education or certifications in Quality Management, Quality Engineering, Lean/Continuous Improvement, Safety, or Food Safety are preferred
6–10 years of overall professional experience in quality, manufacturing, or related environments
3–5 years of experience in food safety and/or continuous improvement initiatives
3–5 years of leadership or supervisory experience, including managing teams and driving quality performance
Advanced proficiency in Microsoft Office and SAP ERP systems
Advanced knowledge of quality tools and methodologies for monitoring performance, analyzing data, and presenting results
Advanced experience with risk analysis tools to support decision-making and problem prevention
Strong problem-solving skills, including managing customer complaints and internal quality incidents

Job Responsibility

Manage and mentor the quality team, providing training and guidance
Acts as the ambassador of quality culture, promoting and embedding SIG quality culture principles throughout the organization to drive continuous improvement, customer satisfaction, and operational excellence
Actively participates in the organization's strategic planning by setting quality objectives that align with business goals and contribute to long-term growth
Lead the implementation and maintenance of the requisites of Quality Pillar, following the guidelines of the SIG Excellence System
Develop and implement quality and food safety management systems in alignment with industry standards and local regulation
Monitor daily operations to ensure quality procedures and specifications are followed
Proactively identify quality risks and improvement opportunities, leading strategic actions that support innovation, compliance, and customer satisfaction
Lead customer quality management through continuous monitoring of customer complaints, management of non-quality costs and customer satisfaction, as well as promoting actions to improve performance and customer service, following global directives
Manage critical incidents and crises involving customers and suppliers, following SIG protocols, leading necessary analyses and improvements, and serving as the focal point for communication with stakeholders involved
Ensure that local changes (e.g., process changes, countermeasures/ learnings from improvement activities or teams) are managed in an effective and efficient way

What we offer

Generous Day 1 eligibility healthcare & life insurance for you and qualified dependents
401K Retirement matching reimbursement
Vacation & PSL
Paid Holidays
Performance Bonus
Opportunity to partially work from home
Personal development opportunities, trainings and coaching opportunities from senior team members

Fulltime

Biological Product Design Owner

Baxter

Location:
Belgium , Braine-l'Alleud

Category:
Research and Development

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 20, 2025

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