Bachelor's degree in Computer Science, Engineering, or related field.
2-5 years of experience in computer system validation or similar role.
Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
Experience validating systems like ERP, LIMS, and MES.
Excellent technical writing and documentation skills.
Strong analytical and problem-solving capabilities.
Ability to work independently as well as collaboratively.
Preferred: Certification in Computer System Validation or related areas.
Experience with cloud-based systems and software validation, specifically Blue Mountain RAM.
3+ years of experience in Computer System Validation and Biotechnology Research.
Responsibilities
Develop and implement validation strategies for systems and applications.
Create and maintain validation documentation including plans and protocols.
Perform risk assessments to identify compliance issues.
Collaborate with teams across IT, Quality Assurance, and Operations.
Conduct validation testing and review outcomes to ensure specifications are met.
Train staff on validation processes and documentation.
Stay updated with industry trends and regulatory changes.
Participate in audits and inspections by regulatory agencies.
Execute Validation Project Plans for manufacturing GxP systems.
Support the qualification of GMP Manufacturing Equipment based on SDLC procedures.
Assist Automation groups with configuring I/O and executing CSV protocols.
Perform lifecycle deliverables including Functional Requirements and Risk Assessments.
Benefits
Opportunities for professional development and training.
Collaborative work environment with cross-functional teams.
Exposure to regulatory audits and industry standards compliance.
Access to cutting-edge technology and systems.
Support for achieving professional certifications in the field.
Full Job Description
Roles & Responsibilities:
Develop and implement validation strategies for computer systems and software applications.
Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
Conduct validation testing and review test results to ensure systems meet specified requirements.
Provide training and support to staff on validation processes and procedures.
Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
Participate in audits and inspections by regulatory agencies.
Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.
Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
Assist site Automation groups in configuring I/O and executing CSV protocol requirements.
Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report
Requirements:
Bachelor's degree in Computer Science, Engineering, or a related field.
Minimum of 2-5 years of experience in computer system validation or a related field.
Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
Experience with validation of various types of systems, including ERP, LIMS, and MES.
Excellent documentation and technical writing skills.
Strong analytical and problem-solving abilities.
Ability to work independently and as part of a team.
Excellent communication and interpersonal skills.
Preferred: Certification in Computer System Validation or related areas.
Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.
3+ years of work experience with Computer System Validation.
