Manager, Senior Engineer - Commissioning, Qualification, 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 rich in diversity. 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:careers.bms.com/working-with-us .

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state-of-the-art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded "Biopharma Company of the Year 2019" in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.

The Role
BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Senior Engineer - Commissioning, Qualification, and Validation (CQV). Reporting to the Senior Manager, Engineering Commissioning, Qualification, and Validation, the successful candidate will join a dynamic team, providing comprehensive support throughout the validation lifecycle of equipment and systems across our campus.

The successful candidate will lead a team of validation specialists to deliver requalifications, periodic review, and all sustaining validation activities required to ensure validated systems and equipment on site continue to operate in their validated state. They will also be responsible for managing the team to complete any temperature mapping activities required to support validation studies or project on site, including qualification of new CTUs, autoclaves, and other process or support equipment. The person will be required to develop and implement robust validation strategies and drive continuous improvement initiatives to enhance the efficiency and effectiveness of the team. This role is pivotal in ensuring that all systems and equipment meet regulatory and quality standards, thereby supporting the overall mission of BMS Cruiserath Biologics.

Key Duties and Responsibilities
Plan, coordinate, and oversee validation activities for all requalifications, periodic reviews and sustaining validation activities for all qualified systems and equipment.
Resource and manage a team to complete temperature mapping for CQV projects, ensuring timely completion and adherence to budgetary constraints to deliver new equipment and equipment upgrades.
Data reviewer on process instrumentation PM/PVs during their sustaining lifecycle.
Ensure compliance with relevant regulatory requirements, such as FDA, EMA, and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9), as well as internal quality standards and procedures. Knowledge and understanding of ASTM E2500 process and procedure.
Conduct risk assessments to identify potential hazards and develop mitigation strategies to ensure the safe and reliable operation of systems and processes.
Prepare and review validation protocols, reports, and standard operating procedures (SOPs), ensuring accuracy, completeness, and compliance with regulatory guidelines.
Collaborate with cross-functional teams, including engineering, quality assurance, and manufacturing, to ensure alignment and coordination of validation activities with overall site objectives.
Develop and implement change control and impact assessment processes, ensuring that any modifications or upgrades to systems and processes are properly validated and documented.
Identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance.
Collaborate with external vendors and contractors to ensure proper installation, qualification, and validation of systems and equipment, including review and approval of vendor documentation.
Provide training and mentorship to validation team members, promoting professional growth and development.
Support internal and external audits and inspections related to validation activities, ensuring compliance and addressing any findings or observations.

Qualifications, Knowledge and Skills Required:
The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline, have extensive experience in the qualification and lifecycle support of GMP systems, and be familiar with developing and implementing validation strategies, managing validation projects, ensuring compliance with regulatory requirements, and conducting risk assessments.
Demonstrated ability to ensure compliance with regulatory requirements and internal quality standards. Proficiency in preparing and reviewing validation protocols, reports, and standard operating procedures (SOPs) with a strong attention to detail is required.
Excellent technical writing skills and experience collaborating with cross-functional teams is essential.
Ability to identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance is beneficial.
Experience working with validation temperature mapping systems and familiar with qualification requirements for CTUs, Autoclaves, HVAC/Utilities and Benchtop Instruments.
Experience supporting internal and external audits and inspections related to validation activities, including addressing findings or observations and implementing corrective actions.
Knowledge of ValGenesis / Paperless Validation software beneficial.

Why you should apply

You will help patients in their fight against serious diseases
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS on-site gym and life assurance.

BMSBL
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If you come across a role that intrigues you but doesn't 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 an inclusive culture, promoting diversity 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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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/

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