CQV Intern

Bristol-Myers Squibb Co; Cruiserath; Hybrid; EUR 22,000 - 27,000; Full time

Job summary

Bristol Myers Squibb invites motivated students for a six, nine, or twelve month CQV Internship. You will gain practical hands-on experience in Commissioning, Qualification and Validation functions and participate in engineering validation activities on site.

You will support design qualification, IQ/OQ/PQ protocol generation, and field walkdowns while working within GMP and data integrity standards. This internship offers exposure to diverse validation projects and professional growth

Qualifications

• Strong collaboration and willingness to learn.
• Strong attention to detail in GMP environments.
• Strong communication skills—written and verbal.
• Ability to work as part of a cross-functional project team.
• Energetic, collaborative and dedicated.

Responsibilities

• 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.

Skills

Pharmaceutical Sciences

Chemical

Biomedical

Bioprocess Engineering

Biotechnology

Computer Applications

Software Engineering

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:

Responsibilities

• 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, collaborative and dedicated.

Compensation Overview

Compensation Overview: 2, 213.90 € per month Pay for this internship/co‑op position is provided in accordance with local market practices and applicable laws. Pay may be offered as an hourly rate and/or monthly stipend, or other locally compliant structure. Pay is determined based on objective factors such as academic level, relevant experience, skills, and work location. Interns and co‑op participants may be eligible for limited benefits depending on program structure, work location, and local requirements. Eligibility and offerings are governed by applicable policies and employment regulations. This is a temporary, time‑bound position intended for the duration of the internship or co‑op program and does not guarantee continued or permanent employment following program completion.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote‑by‑design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607027 : CQV Intern Data Privacy Link

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.