Senior Engineer , Validation

Working with Us

Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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 with the resources to pursue their goals, both at work and in their personal lives. Read more:

• Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
• Acts as a validation SME providing support to multi‑function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Executes multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.
• Work collaboratively with peers within the cross‑functional teams (Facilities and Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance and Quality Engineering Validation) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
• Regularly reviews, prioritises, and promptly responds to customer equipment qualification and support requests.
• Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
• Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works to address perceived deficiencies.
• Foster a culture of compliance, quality, and continuous improvement within the validation team.
• Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance.
• Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes.
• Collaborate with cross‑functional teams to address any findings related to validation and implement corrective actions as necessary.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including but not limited to analytical instruments, autoclaves and environmental monitoring systems.
• Implement risk‑based validation approaches to optimise processes and reduce validation cycle times while maintaining the highest quality.
• Identify opportunities for process optimisation and efficiency improvements within the validation function, collaborating with cross‑functional teams as needed.
• Develop and deliver training programmes for validation team members to enhance their capabilities and knowledge of validation principles and practices.

• Bachelor’s Degree in life sciences, engineering, STEM or equivalent years of experience.
• 5+ years of commissioning, qualification and validation (CQV) experience within technical and regulated industries.
• Robust knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21
  
  CFR part 11, computer systems validation requirements, EU GMP Annex 15 and data integrity requirements.
• Experience with equipment, utility and facility qualifications and general commissioning,…