CQV Intern at Bristol Myers Squibb in Cruiserath

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Inspire and be inspired. We offer a variety of opportunities for undergraduate and post-graduate students to use your talent, skills, education and passion to help make an impact on patient’s lives – all while growing your career and earning academic credit. Our Internship Programme gives you a real opportunity to gain practical ‘hands-on’ experience, training and shadow the experts of your chosen field. It also provides you with insight into what it’s like to work with us. We will place you in a six, nine or twelve month Internship Programme depending on the requirements of your degree course. So, are you ready to embark on a new adventure? We can’t wait to see what you’re made of! During your placement as Commissioning, Qualification and Validation Intern you will get experience of working with one of our Equipment Validation and Computer System Validation functions and you will get exposure to various Engineering Validation activities such as: Utilisation of LIVES Thermal Mapping Equipment to support revalidation of SIP systems on fixed stainless steel process equipment. Generate, execute and review Thermal Mapping Reports and analyse PI/PAS trend data to assess system performance against defined acceptance criteria Identify process improvement opportunities within equipment and SIP qualification workflows to improve the performance and compliance posture of the department Generation of Design Qualification (DQ) documentation for new equipment installations on site, ensuring equipment is assessed against defined User Requirement Specifications (URS) prior to qualification Generation of IQ/OQ/PQ protocols and driving review and approval on ValGenesis in preparation for field executions Generation and approval of subsequent qualification summary reports for Equipment/SIP Validation work, including compilation of executed test evidence and deviation documentation Updating validation operational procedures under guidance from the Senior Validation Engineer Performing review of executed validation documentation for adherence to GMP, data integrity standards, and ALCOA+ principles Responsibility for assigned CSV periodic reviews and informing the CSV Manager of progress against defined timelines Review and assisting in executing CSV protocol test scripts in ValGenesis in accordance with cGMP, applicable regulatory requirements (EU GMP Annex 11, 21 CFR Part 11), the Computer System Validation Master/Project Plan, and BMS Policies, Procedures & Guidelines, to ensure systems are robustly tested and fit for intended use Participation in field walkdowns of new equipment installations to verify all components and connections are installed as per approved P&IDs and engineering specifications Generating and circulating reports from quality system for open quality actions. What Qualities Are We Looking For? We are looking for highly motivated individuals who can collaborate in teams and have the willingness to learn. Pharmaceutical Sciences, Chemical, Biomedical or Bioprocess Engineering, Biotechnology, Computer Applications or Software Engineering discipline of study Passionate about the biopharma sector and innovation in healthcare Strong attention to detail, in a GMP environment the quality of your documentation is as important as the quality of your technical work Strong communication skills — both written and verbal Ability to work as a member of a cross-functional project team Energetic, col