Hands-On CQV Intern in Biopharma Validation

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

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