Bristol Myers Squibb Automation and IT Quality Lead in Cruiserath, Ireland
Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.
Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Cruiserath, Dublin 15, approximately a $1 billion investment. Once commissioned, the new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.
BMS’s Multi Product Cell Culture (MPCC) Facility Cruiserath is seeking to recruit a permanent Automation and IT Quality Lead. The Automation and IT Quality Lead (AIT-QL) is a key leader and part of the BMS team to add biologics Multi Product Cell Culture manufacturing capacity to the BMS network outside the US.
A typical day might include the following:
Maintains an approved inventory of site Automation and IT systems. (on ServiceNow)
Ensures that all Automation and IT systems are configured correctly on the IT call tracking and issue resolution systems.
Ensures that all IT and Automation systems meet BMS policy, Sarbanes-Oxley, FDA 21 CFR 11, Data Integrity and EU Annex 11 regulations.(Liase with global and local validation)
Agrees the site strategy and processes for IT and Automation Standard Operating Procedures and Work Instructions to ensure systems have required operation and maintenance activities in place.
Manages a schedule of required periodic activities to ensure they are completed on time e.g. Disaster Recovery Testing, Periodic Reviews, User access reviews, data archive activities, etc. (performance monitoring)
Creates weekly management status reports for commitments including Training, CAPA, CMMS and Change Control. (add in change control champion)
Owns ACR list and process
Creates monthly reports on compliance KPI’s.
Works closely with the validation and quality departments to ensure that site computer system requirements are clearly specified and that the computer system validation lifecycle has the necessary controls in place to ensure adherence to compliance requirements.
Supports the development of a world class compliance culture and focus on continuous improvement.
Represents the IT and Automation department in internal audits and external regulatory audits. (add manages Audit prep)
Ensures the IT and Automation department is in a state of continuous audit readiness.
Maintains job descriptions and position curricula for all IT and Automation department employees and contractors.
Ensures supplier assessments/audits (under validation) and safety statements are in place for all main contractors.
This job might be for you if:
Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences. (need someone technical who has CSV experience)
At least 8 years’ experience in computer system validation and/or compliance within the pharmaceutical industry.
Experienced in assessment and remediation strategies of systems to meet computer system Sarbanes-Oxley, 21 CFR 11 and EU Annex 11 requirements.
Experienced with IT Infrastructure, Process Automation, Laboratory systems and Enterprise systems.
Experience during computer system project delivery conducting and managing compliance programs including general cGMP activities.
Ability to keep work pace and meet deadlines. Good organising and planning skills.
Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
Proven success working well in a team environment with flexibility to react to changing business needs.
Experienced in the development and presentation of strategies to senior management.
Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
Ability to work independently and remotely with minimum direct supervision.
Strong Customer relationship management skills.
Strong Critical thinking skills.
Industry collaboration and influencing skills.
Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
Certification in auditing with ITIL/ISO preferred.
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
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, life assurance, on-site gym and gain-sharing bonus
Apply now by clicking the Apply button, or email me at email@example.com for more information.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled