Manager, Computer System Validation

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years employing people across a range of activities and business units in Utrecht The Netherlands.

The Netherlands is also home to our firstEuropean Cell Therapy facility located at the Leiden Bio Science Park the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey.Check out this videoif you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancerJoin us and be a game changer!

For more information about Bristol Myers Squibb Netherlands visit us at Summary

This position will drive computer system validation activities for the Leiden site Manufacturing Execution Systems (MES) supporting the Leiden Cell Therapy manufacturing site. This role is ideal for someone with a strong IT/Computer Science foundation and 5 years or more of hands-on experience in the pharma/biotech industry. Youll partner with other cross-functional teams such as QA Business and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support.

Duties/Responsibilities

• Lead end-to-end validation activities including test preparation authoring of IQ/System/UAT scripts Dry Run test data setup environment readiness test execution facilitation and post-execution review.
• Coordinate recipe configuration master data setup and validation in Syncade MES.
• 3 years of experience with Emerson Syncade MES including knowledge of recipes equipment and material management and MES implementations in the pharmaceutical area.
• Author Review and Approve validation documentation lifecycle: Validation & Test Plan requirement Test Scripts Assessment documents and Summary Reports.
• Validate electronic batch records (EBR) MES recipes interfaces and integration with systems such as SAP Oracle LIMS CMMS GPS and EDMS.
• Ensure all activities comply with 21 CFR Part 11 GAMP 5 and internal SOPs.
• Strong project management skills (organization collaboration multi-tasking and communication) high degree of attention to detail and the ability to perform well in a team-based environment are required.
• Provide assistance as needed to support Health Authority inspections and internal audits.
• Assist with investigations triage deviations and ensure CAPAs are addressed and implemented for MES.
• Assist with program metrics by developing applicable tools and trackers generating and analyzing quality system data for trending performance deficiencies and conformance to appropriate action plans as needed to remediate or continually improve on quality system performance.
• Collaborate with Business Owners QA and IT to align on requirements and ensure CSV deliverables are compliant and audit ready.
• Ensure validation practices meet GAMP 5 CSA 21 CFR Part 11 and ALCOA data integrity principles.
• Required Competencies
• Proven ability to manage competing priorities with a flexible workstyle and consistently deliver efficient compliant results in fast-paced cross-functional environments.
• Experienced in cross-functional communication with the ability to interpret and convey business and IT needs for Validation comfortable interacting with QA business and technical teams.
• Understanding of MES Syncade & Recipes testing phases (IQ System Testing Recipe UAT).
• Familiarity with cGMP GAMP SDLC 21 CFR Part 11 and Good Documentation Practices (GDP).
• Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups

Reporting Relationship

• Senior Manager IT Quality and Compliance.

Specific Knowledge Skills Abilities

• Specific Knowledge Skills Abilities:
• Bachelors in engineering IT Science field or equivalent
• Experience with MES platforms (Syncade preferred) and electronic batch records (EBR).
• Familiar with tools such as ALM ServiceNow SQL databases and document management systems.
• Knowledge of shop floor operations process automation and manufacturing environments are preferable
• 5 years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments with strong knowledge of GAMP 5 21 CFR Part 11 and Computer Software Assurance (CSA) principles.
• 3 years of hands-on MES experience with Emerson Syncade including recipe validation EBR testing and interface verification with systems such as SAP LIMS and Oracle.
• Experience with project management demonstrating the ability to prioritize urgent tasks manage competing deadlines and adapt effectively within dynamic cross-functional teams.
• Experience with ALM ServiceNow SQL databases and document management systems (e.g. Veeva BMSDocs) supporting testing issue tracking and controlled documentation

Disclaimer: For any third parties or external agencies please be informed we do not accept unsolicited requests proposals applications or profiles for any of our roles at BMS.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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