Advanced Software Engr
Honeywell · Posted Nov 4
Building automation, industrial automation, aerospace, and energy-efficient technology solutions
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About the role
The role sits at the intersection of IT solutions and Quality Assurance in the life sciences industry, ensuring QMS software operates accurately, securely, and in compliance with regulatory standards. It involves validation documentation, regulatory compliance, risk management, change control, training, and audit support for QMS implementations.
What you will do
- A QMS Validation Specialist in the Life Sciences industry is responsible for ensuring that Quality Management System (QMS) software operates accurately, securely, and in compliance with strict regulatory standards. They bridge the gap between IT solutions and Quality Assurance (QA).
- Validation Documentation: Create, review, and execute validation lifecycle documents, including Validation Plans (VP), User Requirement Specifications (URS), Functional Requirements Specifications, Traceability Matrices (RTM), and Test cases for IQ/OQ/PQ.
- Regulatory Compliance: Ensure QMS systems align with global life science regulations like FDA 21 CFR Part 11 (electronic records and signatures), EU Annex 11, and GAMP 5 guidelines for software validation.
- Risk Management: Conduct risk assessments (e.g., FMEA) to identify and mitigate compliance or data integrity gaps.
- Change Control & CAPA: Manage software changes, deviations, and Corrective and Preventive Actions (CAPA).
- Training & SOPs: Develop training materials and Standard Operating Procedures (SOPs) to ensure end-users utilize the QMS software securely and compliantly.
- Audit Support: Act as the Subject Matter Expert (SME) during internal audits and external regulatory inspections regarding the QMS implementation.
Skills used in this role
What the employer is looking for
- Education: Bachelor’s degree in Life Sciences, Biotechnology, Computer Science, or Engineering.
- Software Platforms: Familiarity with modern enterprise QMS platforms like TrackWise Digital, Veeva Vault Quality, MasterControl or ValGenesis.
- Validation Frameworks: Deep practical knowledge of GAMP 5, data integrity principles, and electronic signatures regulations.
- Strong analytical and technical writing capabilities.
- The ability to translate complex IT and quality concepts into understandable terms for cross-functional stakeholders.
- High attention to detail with an ability to manage multiple validation projects simultaneously.
Benefits and support
- Compensation and benefits are detailed in the job posting
About Honeywell
Honeywell is a multinational conglomerate corporation that invents and manufactures technologies addressing tough challenges linked to global macrotrends such as safety, security, and energy. It operates major business divisions focusing on building automation, industrial automation, and enterprise performance solutions. Through continuous innovation, the company helps drive smarter, safer, and more sustainable operations worldwide.
- Industry
- Conglomerate
- Company size
- 101000+ employees
- Founded
- 1906
- Location
- Charlotte, North Carolina, USA
- Funding stage
- Public Company
Leadership
Chairman and Chief Executive Officer
Mike Stepniak
Senior Vice President and Chief Financial Officer
Suresh Venkatarayalu
Senior Vice President and Chief Technology Officer
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