COMPUTER SYSTEMS VALIDATION ENGINEER

Company: Sequoia Biotech Consulting
Location: Cambridge
Posted on: October 31, 2024

Job Description:

Company Description

Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

For more information, visit www.sequoiabiotech.com/.

What you will be doing:

We are seeking a highly skilled Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be responsible for ensuring that all computer systems and software used by our clients comply with regulatory requirements and industry standards. This role involves planning, executing, and documenting validation activities to ensure the integrity and reliability of these systems.

Is this job for you?

• 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:
  • BMS/EMS/PCS systems such as Rees, Metasys, DeltaV, OSI PI
  • Computerized maintenance systems such as Blue Mountain Regulatory Asset Management, Maximo, Infor10
  • 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 Who you are:
      • Bachelor's degree in Computer Science, Engineering, or a related field.
      • Minimum of 4-7 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. We Provide a Comprehensive Total Rewards Program Not Limited To:
          • Excellent healthcare options: Medical, vision, prescription & dental.
          • Family Focus & Balance: Parental leave, flexible time-off, and Employee Assistance Program.
          • Financial Security: 401(k) with employer matching.
          • Tuition Reimbursement: Continuing education for every season of your career.
          • Employee Recognition Programs.
            Compensation: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
            
            Legal Statement
            Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

Keywords: Sequoia Biotech Consulting, Portland , COMPUTER SYSTEMS VALIDATION ENGINEER, IT / Software / Systems , Cambridge, Maine