Computer System Validation Engineer

Engineering

icon-location-marker Cruiserath - IE
Posted 23 days ago Full_time R1517971

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb has built a new state of the art Multi product biologics manufacturing facility in Cruiserath, Dublin 15, approximately $900 million investment. The new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network. The facility consist of a linked manufacturing building and a Laboratory, Office and Canteen building.

As part of the project a separate Global biologics laboratory (GBL) was built and validated in 2015 to enable testing and release of Biological drug substances for the BMS network.  The analytical equipment in the GBL laboratory will now be transferred to the LOC building and subjected to computer system revalidation and data migration.

BMS Cruiserath Biologics is seeking to recruit a permanent Computer System Validation Engineer to support changes to validated systems on site and to support introduction of new computerised systems to the site.  The Computer System Validation Engineer will report into the Computer System Validation Manager on progress on assigned tasks and assist in the update of the governing CSV documentation aligned with corporate and regulatory guidelines.

Key Duties and Responsibilities:

  • Responsibility for assigned CSV validation projects and informing CSV manager of progress against defined timelines.
  • Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines to ensure robust tested systems, which are fit for use.
  • Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits.
  • Drafting and approval of CSV documentation for system upgrades, changes and general validation challenges, and providing support in identifying the need for creation/updating operating procedures or templates.
  • Updating CSV operational procedures and performing peer review of documentation and additional duties as required by management.
  • Responsible for performing Computerised system periodic reviews across the site and ensuring defined timelines are achieved.

Qualifications, Knowledge and Skills Required:

  • The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, IS/IT, technical or engineering discipline along with 2+ years of experience in validation at biologics manufacturing operations. 
  • A background in validation of computerized system in biologics manufacturing sites is desired.
  • Knowledge of requirements for design, installation, Commissioning, Qualification and Validation of computerized systems using risk-based approaches.
  • Knowledge of regulatory validation requirements including FDA (21 CFR part 11), EMA (Annex 11), ISPE (GAMP 5) and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level:

Passion: We pursue excellence to help patients prevail.

Innovation: We embrace new ideas.

Accountability: We own our outcomes and the outcomes of others.

Speed: We act with urgency and agility.

Why should you apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,  life assurance, on-site gym and gain-sharing bonus.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.