OT
Sr. Validation Engineer For Life Sciences
Accepting applicationsOnShore Technology Group · Chicago, IL
Full-Time Mid_senior AI
Posted
4d ago
Category
Verification
Experience
Mid_senior
Country
United States
Company Description OnShore Technology Group is a global Independent Verification and Validation (IV&V) firm focused on optimizing and streamlining validation processes for life sciences and other highly regulated industries. The company pioneered the concept of “Lean Validation” and leads the field in IV&V innovation through its proprietary ValidationMaster platform. ValidationMaster is a scalable, configurable enterprise digital validation management and quality system built on a Microsoft framework and enhanced with AI/ML, supporting organizations worldwide in multiple languages. OnShore has received multiple industry awards, including recognition as a top life science IV&V software and services firm and inclusion in the Inc. 5000 list of fastest-growing private companies.
Role Description The Sr. Validation Engineer for Life Sciences is a full-time, hybrid role based in Chicago, IL, with flexibility to work in the office and at home as required. This role is responsible for planning, executing, and documenting validation activities for life sciences systems and processes, ensuring compliance with regulatory requirements and internal quality standards. Day-to-day tasks include developing validation plans, protocols, and reports; performing risk assessments; conducting testing and functional verification; and troubleshooting issues identified during validation and qualification efforts. The Sr. Validation Engineer collaborates closely with cross-functional teams, including quality, IT, manufacturing, and project management, to implement Lean Validation methodologies and support the deployment of platforms such as ValidationMaster. The role also involves mentoring junior team members, contributing to continuous improvement initiatives, and staying current with evolving regulatory and cybersecurity expectations impacting computer system validation, process validation, equipment commissioning and qualification (EC&Q), lab validation, cleaning validation, and other various types of validation projects within life sciences
Qualifications
A minimum of 10+ years of practical, hands-on validation experience within the life sciences industry.
Very Strong interpersonal and (advanced) technical writing skills
Minimal supervision required, detailed oriented
Must have a working knowledge of AI/ML.
Advanced working knowledge of validation processes for CSV, EC&Q, and process validation
Self-motivated, energetic, enthusiastic, willing to learn and a positive attitude
Working knowledge of validation industry standards including, but not limited to ISPE GAMP 5, FDA CSA methodology, et al.
Automated testing experience preferred.
Must be willing to go the extra mile and contribute to the overall success of the company
The ideal candidate is highly adaptable and must be ready to adapt to changes in priorities and project schedules as needed.
Familiarity with advanced technologies including ERP/MRP/LIMS/EQMS and other technologies used by life sciences companies. Familiarity with Microsoft Dynamics 365 For Finance & Operations, Microsoft Business Central, Oracle Fusion Cloud, Oracle e-Business, SAP, BPA Solutions, AI technologies, Veeva, SharePoint Modern Experience, and many others is a must.
Preparation of full lifecycle validation documentation including but not limited to validation plans, risk assessments, project plans, URS/FRS/DS specifications, test plans, system security plans, migration plans, configuration specifications, validation test cases including (IQ/OQ/PQ/UAT), validation summary documentation and related validation process deliverables.
Experience applying Good Manufacturing Practice (GMP) principles to computer system and process validation.
Proficiency in Debugging and issue resolution within complex, regulated technology environments.
Bachelor’s degree in engineering, life sciences, computer science, or a related technical discipline; advanced degree is a plus.
Demonstrated experience in life sciences, pharmaceuticals, medical devices, biotechnology, chemical, or other highly regulated industries.
Advanced knowledge of quality assurance principles and agile methodologies. Must have a solid grasp of DevSecOps/Agile environments to ensure continuous validation and seamless adaptation to changing requirements.
Knowledge of relevant regulations and standards (e.g., FDA, IEEE 1012, EMEA, GxP, 21 CFR Part 11, Annex 11, ALCOA+, data integrity, EU GDPR, et al).
Ability and flexibility to work effectively in a hybrid environment, manage multiple projects, and communicate complex technical and validation concepts clearly to diverse stakeholders.
Must be able to work overtime weekends on occasion, if required. This is a mandatory requirement. WILL NOT consider any candidate who cannot work overtime as needed.
Experience with validation management tools or platforms (experience with ValidationMaster or similar systems is an advantage). Must be willing to adapt to using advanced technologies including AI/ML
What Do We Find Important?
We operate globally, yet remain an independent, privately-held business committed to investing in our product and service offerings and most importantly, our people. OnShore’s corporate values (Integrity, Innovation, Honesty, Openness, Teamwork) are the foundation of our everyday activities. Therefore, it is essential that potential candidates are compatible with our values. Successful candidates are flexible, supportive, passionate and always go the extra mile for our clients. We value open communication and always seek to bring out the best in each team member.
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Role Description The Sr. Validation Engineer for Life Sciences is a full-time, hybrid role based in Chicago, IL, with flexibility to work in the office and at home as required. This role is responsible for planning, executing, and documenting validation activities for life sciences systems and processes, ensuring compliance with regulatory requirements and internal quality standards. Day-to-day tasks include developing validation plans, protocols, and reports; performing risk assessments; conducting testing and functional verification; and troubleshooting issues identified during validation and qualification efforts. The Sr. Validation Engineer collaborates closely with cross-functional teams, including quality, IT, manufacturing, and project management, to implement Lean Validation methodologies and support the deployment of platforms such as ValidationMaster. The role also involves mentoring junior team members, contributing to continuous improvement initiatives, and staying current with evolving regulatory and cybersecurity expectations impacting computer system validation, process validation, equipment commissioning and qualification (EC&Q), lab validation, cleaning validation, and other various types of validation projects within life sciences
Qualifications
A minimum of 10+ years of practical, hands-on validation experience within the life sciences industry.
Very Strong interpersonal and (advanced) technical writing skills
Minimal supervision required, detailed oriented
Must have a working knowledge of AI/ML.
Advanced working knowledge of validation processes for CSV, EC&Q, and process validation
Self-motivated, energetic, enthusiastic, willing to learn and a positive attitude
Working knowledge of validation industry standards including, but not limited to ISPE GAMP 5, FDA CSA methodology, et al.
Automated testing experience preferred.
Must be willing to go the extra mile and contribute to the overall success of the company
The ideal candidate is highly adaptable and must be ready to adapt to changes in priorities and project schedules as needed.
Familiarity with advanced technologies including ERP/MRP/LIMS/EQMS and other technologies used by life sciences companies. Familiarity with Microsoft Dynamics 365 For Finance & Operations, Microsoft Business Central, Oracle Fusion Cloud, Oracle e-Business, SAP, BPA Solutions, AI technologies, Veeva, SharePoint Modern Experience, and many others is a must.
Preparation of full lifecycle validation documentation including but not limited to validation plans, risk assessments, project plans, URS/FRS/DS specifications, test plans, system security plans, migration plans, configuration specifications, validation test cases including (IQ/OQ/PQ/UAT), validation summary documentation and related validation process deliverables.
Experience applying Good Manufacturing Practice (GMP) principles to computer system and process validation.
Proficiency in Debugging and issue resolution within complex, regulated technology environments.
Bachelor’s degree in engineering, life sciences, computer science, or a related technical discipline; advanced degree is a plus.
Demonstrated experience in life sciences, pharmaceuticals, medical devices, biotechnology, chemical, or other highly regulated industries.
Advanced knowledge of quality assurance principles and agile methodologies. Must have a solid grasp of DevSecOps/Agile environments to ensure continuous validation and seamless adaptation to changing requirements.
Knowledge of relevant regulations and standards (e.g., FDA, IEEE 1012, EMEA, GxP, 21 CFR Part 11, Annex 11, ALCOA+, data integrity, EU GDPR, et al).
Ability and flexibility to work effectively in a hybrid environment, manage multiple projects, and communicate complex technical and validation concepts clearly to diverse stakeholders.
Must be able to work overtime weekends on occasion, if required. This is a mandatory requirement. WILL NOT consider any candidate who cannot work overtime as needed.
Experience with validation management tools or platforms (experience with ValidationMaster or similar systems is an advantage). Must be willing to adapt to using advanced technologies including AI/ML
What Do We Find Important?
We operate globally, yet remain an independent, privately-held business committed to investing in our product and service offerings and most importantly, our people. OnShore’s corporate values (Integrity, Innovation, Honesty, Openness, Teamwork) are the foundation of our everyday activities. Therefore, it is essential that potential candidates are compatible with our values. Successful candidates are flexible, supportive, passionate and always go the extra mile for our clients. We value open communication and always seek to bring out the best in each team member.
Show more Show less