CrawlJobs Logo

Biological Product Design Owner

https://www.baxter.com/ Logo

Baxter

Location Icon

Location:
Belgium , Braine-l'Alleud

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Employment contract

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

This role is responsible for managing technical outcomes through indirect management of individuals and teams, handling Design Control, CAPA, and Change Control projects, providing design leadership, and ensuring compliance with quality standards and regulatory requirements.

Job Responsibility:

  • Achieves desired technical outcomes through the indirect management of individuals and teams(s) and the direct completion of complex Design Control, Corrective Action Preventative Action (CAPA), Change Control (CC) projects or programs within the boundaries of timing and budget
  • Reviews and approves complex design changes with technical staff and provides technical product direction
  • Provides technical and design-leadership
  • Fosters an environment of rigor, completeness, and compliance when participating on plant CAPA, CC or Field Corrective Action investigations/assessments
  • Responsible for technical and project management of a constantly changing initiative portfolio
  • Responsible for triage escalation to global R&D team members and managing stakeholder expectations
  • Manages innovative technical solutions to complex product-related problems
  • Maintains current knowledge of relevant quality standards and regulatory requirements

Requirements:

  • Relevant technical discipline, preferably an advanced degree in Chemistry/Biology/Chemical Engineering or equivalent
  • 1 up to 5 years of experience with a Bachelor degree or 0 up to 2 years of experience with a Master degree
  • Excellent communication skills – both written and oral
  • Ability to work effectively independently and in team environment
  • Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics
  • General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs
  • Comfortable in analyzing and solving complex problems within a risk-based approach
  • Aptitude in managing cross-functional, cross-facility teams and projects of a diverse nature

Nice to have:

  • Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics
  • General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs
What we offer:
  • Support for Parents
  • Continuing Education/Professional Development
  • Employee Health & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Baxter - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

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

Briefcase Icon

Similar Jobs for Biological Product Design Owner

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...
Location
Location
United States , Thousand Oaks
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right
New

Principal Software Engineer

Microsoft’s Azure Data engineering team is leading the transformation of analyti...
Location
Location
United States , Redmond
Salary
Salary:
139900.00 - 274800.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Computer Science or related technical field AND 6+ years technical engineering experience with coding in languages including, but not limited to, C, C++, C#, Java, JavaScript, or Python - OR equivalent experience
  • 3+ years experience in distributed systems, client-server architecture, and distributed database technologies
  • Ability to meet Microsoft, customer and/or government security screening requirements are required for this role
Job Responsibility
Job Responsibility
  • Design, build, and deliver distributed database capabilities that provide customer value in security, performance, reliability, usability, and manageability, while aligning with business objectives
  • Advance the integration of Cosmos DB with Microsoft Fabric, powering seamless analytics and operational data scenarios through Cosmos DB in Fabric and Cosmos DB Mirroring
  • Partner with teams across Azure and Microsoft Fabric to deliver end-to-end solutions that improve resiliency, reliability, and performance at global scale
  • Shape the long-term architecture and technical direction of distributed systems within Cosmos DB
  • Mentor and guide engineers on the team, promoting growth, collaboration, and technical excellence
  • Elevate engineering practices by driving design reviews, improving code quality, and strengthening operational excellence
  • Embody our culture and values
  • Fulltime
Read More
Arrow Right
New

Account Executive

As a member of Baxter’s sales team, you’ll be aligned to one of our global busin...
Location
Location
United States , Tacoma
Salary
Salary:
80000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree and 5+ years of sales experience OR 8+ years of sales or related experience with high school diploma or GED
  • Medical device sales preferred
  • Cardiology experience preferred
  • Proven track record of achieving sales goals and market share growth
  • Experience selling disruptive technology and launching new products in a competitive environment
  • Skilled in sales solutions development, negotiation, and closing complex deals
  • Ability to manage long sales cycles and adapt to evolving sales strategies
  • Excellent presentation, communication, and active listening skills
  • Strong attention to detail with CRM and compliance-related documentation
  • Self-motivated, goal-oriented, and resilient in the face of rejection
Job Responsibility
Job Responsibility
  • Drive sales of medical devices and solutions to physicians, hospitals, and healthcare systems
  • Optimally develop and maintain a pipeline of opportunities by prospecting, developing, forecasting, and closing new business opportunities to achieve sales objectives
  • Build strong stakeholder relationships, including champions and advocates within hospital systems
  • Deliver effective sales presentations and communicate complex medical/technical information clearly
  • Provide product education, service, and training to healthcare providers
  • Consistently achieve and exceed sales targets with a history of forecasting accuracy
  • Collaborate with other Account Executives, managers, and support staff to deliver results
  • Maintain compliance with CRM and all regulatory documentation requirements
  • Represent the company professionally and confidently in front of physicians and decision-makers
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right
New

Account Executive

As a member of Baxter’s sales team, you’ll be aligned to one of our global busin...
Location
Location
United States , Ann Arbor
Salary
Salary:
80000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree and 5+ years of sales experience OR 8+ years of sales or related experience with high school diploma or GED
  • Medical device sales preferred
  • Cardiology experience preferred
  • Proven track record of achieving sales goals and market share growth
  • Experience selling disruptive technology and launching new products in a competitive environment
  • Skilled in sales solutions development, negotiation, and closing complex deals
  • Ability to manage long sales cycles and adapt to evolving sales strategies
  • Excellent presentation, communication, and active listening skills
  • Strong attention to detail with CRM and compliance-related documentation
  • Self-motivated, goal-oriented, and resilient in the face of rejection
Job Responsibility
Job Responsibility
  • Drive sales of medical devices and solutions to physicians, hospitals, and healthcare systems
  • Optimally develop and maintain a pipeline of opportunities by prospecting, developing, forecasting, and closing new business opportunities to achieve sales objectives
  • Build strong stakeholder relationships, including champions and advocates within hospital systems
  • Deliver effective sales presentations and communicate complex medical/technical information clearly
  • Provide product education, service, and training to healthcare providers
  • Consistently achieve and exceed sales targets with a history of forecasting accuracy
  • Collaborate with other Account Executives, managers, and support staff to deliver results
  • Maintain compliance with CRM and all regulatory documentation requirements
  • Represent the company professionally and confidently in front of physicians and decision-makers
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right
New

Senior Principal Software Systems Engineer

Join our dynamic team as a Senior Principal Software Systems Engineer in the R&D...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right
New

Principal Technical Program Manager - Copilot Identity

Copilot Security is at the heart of Microsoft’s mission to deliver trusted, huma...
Location
Location
United States , Redmond
Salary
Salary:
139900.00 - 274800.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree AND 6+ years experience in engineering, product/technical program management, data analysis, or product development OR equivalent experience
  • 3+ years of experience managing cross-functional and/or cross-team projects
  • 3+ years of hands-on experience with authentication and identity systems, including practical knowledge of protocols (e.g., OAuth 2.0, OpenID Connect, SAML), session management, MFA, federation, and directory services
  • Experience reading and/or writing code (e.g., sample documentation, product demos)
  • Proven track record driving feature launches and large-scale rollouts in complex systems, ideally across multiple client surfaces (desktop, web, mobile)
  • Experience defining long-term program vision and strategy for identity/security projects
  • proficiency with OKRs and KPI-driven execution
  • Excellent communication, collaboration, and influence skills
  • ability to crisply communicate technical concepts to diverse audiences
  • Ability to thrive in fast-paced, ambiguous environments while driving clarity, alignment, and results
Job Responsibility
Job Responsibility
  • Lead and orchestrate identity improvement programs across multiple client surfaces (e.g., desktop, web, and mobile), aligning roadmaps and milestones with partner teams and the Microsoft central identity system
  • Partner with research, engineering, and product managers to scope initiatives, define success metrics, and plan phased delivery that reduces risk and accelerates customer value
  • Ensure data quality, availability, and compliance for identity-related telemetry and signals
  • work with stakeholders to meet all privacy, security, and compliance requirements for shipping features at scale
  • Drive execution excellence: define schedules, milestones, KPIs, and review cadences
  • track progress, manage dependencies, surface risks, and ensure on-time delivery
  • Communicate program status, insights, and blockers with leadership and stakeholders
  • clarify ownership, hold teams accountable, and cultivate durable cross-org partnerships
  • Manage program execution and stakeholder engagement across geographically distributed teams, proactively addressing time zone challenges and fostering effective communication
  • Schedule and facilitate meetings, reviews, and decision-making sessions that accommodate global team members, ensuring all voices are heard and progress remains on track
  • Fulltime
Read More
Arrow Right
New

Principal Software Systems Engineer

Join our dynamic team as a Principal Software Systems Engineer in the R&D/Softwa...
Location
Location
United States , Raleigh
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks.Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right
New

Principal Technical Program Manager - Copilot Security

Copilot Security is at the heart of Microsoft’s mission to deliver trusted, huma...
Location
Location
United States , Redmond
Salary
Salary:
139900.00 - 274800.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree AND 6+ years experience in engineering, product/technical program management, data analysis, or product development OR equivalent experience
  • 3+ years of experience managing cross-functional and/or cross-team projects
Job Responsibility
Job Responsibility
  • Lead and orchestrate AI security programs across multiple client surfaces (desktop, web, mobile), aligning roadmaps and milestones with partner teams and Microsoft’s central security ecosystem
  • Drive feature development for prompt injection defenses, intent-based detection systems, and security control sets, leveraging the latest research and industry frameworks (e.g., NIST COSAIS, CSA AI Controls Matrix)
  • Partner with engineering, research, and product managers to scope initiatives, define success metrics, and plan phased delivery that reduces risk and accelerates customer value
  • Implement novel defense-in-depth strategies like cross-prompt isolation (XPIA), adaptive threat detections, agentic adversarial testing, and secure model lifecycle practices
  • Ensure data quality, privacy, and compliance for AI-related telemetry and signals
  • work with stakeholders to meet all regulatory and security requirements for shipping features at scale
  • Drive execution excellence: define schedules, milestones, KPIs, and review cadences
  • track progress, manage dependencies, surface risks, and ensure on-time delivery
  • Communicate program status, insights, and blockers with leadership and stakeholders
  • clarify ownership, hold teams accountable, and cultivate durable cross-org partnerships
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Poland Jobs Germany Jobs Ireland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy