Bachelor's degree in Computer Science, Engineering, or related field
2-5 years of experience in computer system validation
Strong knowledge of FDA, EMA regulations and GAMP 5 standards
Experience with validation of ERP, LIMS, and MES systems
Excellent documentation and technical writing skills
Strong analytical and problem-solving abilities
Ability to work independently and collaboratively
Excellent communication and interpersonal skills
Preferred: Certification in Computer System Validation
Experience with cloud systems and Blue Mountain RAM
3+ years of Biotechnology Research experience
Responsibilities
Develop and implement validation strategies for computer systems and software applications
Create and maintain validation documentation
Perform risk assessments to identify potential compliance issues
Collaborate with cross-functional teams for system validation
Conduct validation testing and review test results
Provide training and support to staff on validation procedures
Stay updated on industry trends and regulatory changes
Participate in audits and regulatory inspections
Execute Validation Project Plans for manufacturing GxP systems
Support qualification of systems for GMP Manufacturing Equipment
Assist in configuring I/O for site Automation groups
Independently perform CSV lifecycle deliverables
Benefits
Ongoing professional development opportunities
Collaborative work environment with cross-functional teams
Exposure to a variety of systems including ERP, LIMS, and MES
Chance to stay at the forefront of industry regulations and technologies
Opportunity to work in the biotechnology sector
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
ssist 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.
bility 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.
