Senior Analyst/ Analyst, Computer System Validation

Company Background

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.

Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.

Job Position

Senior Analyst / Analyst, Computer System Validation

Reports to

Senior Manager, Computer System Validation

 Job Description

Computer Systems Validation (CSV)

  • Generate or review of CSV plans, qualifications test protocols, traceability matrices, reports, and deliverables within the scope of the validation plan
  • Participating in the validation of computerized systems
  • Providing technical support and participating in the implementation of change controls and commitment action items
  • Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs
  • Evaluate proposed changes to validated computer systems and recommend level of validation activities required
  • Perform project management activities for CSV process within the scope of an overall system project
  • Work with overall project manager to include validation activities in implementation timelines
  • Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents

Business Applications

  • Manage Project to ensure timely completion of projects within the timeline and cost
  • Define, design, and document business flows and processes on small to large projects
  • Define and articulate business rules required for data accuracy and consistency
  • Ensure data integrity is maintained at all time
  • Ensure that systems conform to applicable regulatory requirements; understand and follow appropriate SDLC, quality validation processes and application processes

Support

  • Day to day operational user support including APAC and US operations

Maintain

  • Implement improvement to existing system to support the changing business requirement
  • Implement data integration between multiple enterprise systems along with future strategy towards enterprise integration platform
  • Execute established policies and procedures to ensure compliance with application development polices and standards

Establish

  • Implement solutions through leveraging standard “out of the box” system functionalities to the greatest extent possible to enable our business partners to be effective, efficient and agile
  • Implement technology solutions for data warehouse and reporting

Communicate

  • Partner with business stakeholders to gather requirements to identify efficient technological solutions
  • Disseminate information in a timely manner within the team and across functions or teams

Participate

  • Execute projects to meet key project milestones and within cost
  • Participate in and contribute effectively to departmental planning and strategy processes

Requirements

  • Bachelor’s degree or equivalent, in Computer Science, Engineering or any related field with at least 6 to 8 years of relevant working experience
  • Prior experience in an GxP-related environment in a Biotech or Pharmaceutical company with computer system validation experience
  • Experience in developing design functional specifications, test scripts, computer system validation and training documents
  • Experience with ERP, QMS, LIMS, BMS/EMS, LMS etc.
  • Possess “can do” attitude to solve problems and take initiative to find opportunities for continuous improvement
  • Process-oriented with an ability to think strategically to reach a sound decision
  • Self-motivated and positive with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills
  • Excellent interpersonal, verbal and written communication and presentation skills and ability to interact and interface with all levels of business including senior leadership team
  • Comfortable in a fast-paced environment with minimal direction, but also able to follow the processes and policies of large corporations