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 and 2021.
For more information about Bristol Myers Squibb, visit us at BMS.com/ie
The Role
BMS Cruiserath Biologics is seeking to recruit on a permanentcontractSenior Specialist, Commissioning, Qualification, Validation Engineering.
This role of CQV Engineer will be responsible for commissioning, qualification, and validation activities at BMS Cruiserath relating to GMP and non-GMP equipment/system types across multiple projects.
Commissioning involves testing systems prior to operations to confirm the correct installation and establishing that it's functioning as intended while complying with Good Engineering Practices and EHS requirements. Qualification involves testing quality-impacting equipment by verifying the necessary functionality required for the end-user and is focused on Good Manufacturing Processes through documenting IQ, OQ and PQ.
Validation processes continue throughout the lifecycle by collecting ongoing performance data to ensure the validated state remains.
Cleaning validation is a process used to provide documented evidence that equipment and facilities are properly cleaned before being used for the production of biopharmaceuticals.
Contamination can be introduced by other product ingredients, cleaning agents, micro-organisms or by other materials (e.g. air-borne particles, dust, lubricants, raw materials, intermediates).
The same equipment may be used for processing different products which may also lead to contamination, therefore adequate cleaning procedures are critical.
This position will report to the Senior Manager, Validation and will work across CQV workstreams with an initial focus on cleaning validation.
Key Duties and Responsibilities:
Performing all aspects of cleaning sampling required for cleaning monitoring and ad-hoc cleaning verification samples.
Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.
Supporting product changeover activities.
Assisting with LOTO (lockout/ Tagout) activities where required.
Generation of standardized cleaning validation ECPs (Energy Control Plans).
Generation of cleaning validation documentation for new product introductions, process changes, audit observations and other required actions.
Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
Cleaning validation release memos to support product release.
Oversight of the visual inspection qualification and requalification process on site.
Developing strategies for the necessary CQV activities for individual projects.
Generating and completing CQV documentation to satisfy requirements and executing test deliverables for CQV testing as applicable.
Adhering to project deadlines as scheduled by the project manager.
Inputting to a wider projects team as CQV representative and liaising with cross-functional teams to ensure timely completion and approval of CQV deliverables.
Investigation support using QMS (Quality Management Systems) and troubleshooting for CQV issues.
Ensuring adherence to governing site and global procedures and regulatory guidelines.
Qualifications, Knowledge and Skills Required:
The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.
Previous cleaning validation / CQV experience is an advantage.
The ideal candidate would have biopharmaceutical Process / Validation knowledge.
Exposure to cGMP in a fast-paced environment is required.
Previous experience in working in a drug product filling facility would be advantageous.
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.
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 Cruiserath on-site gym and life assurance.
BMSBL
#LI-Hybrid
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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