Job Information
Bristol Myers Squibb Manager, Engineering Commissioning, Qualification and Validation in Cruiserath, Ireland
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.
Position Summary
BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Engineering Commissioning, Qualification and Validation . Reporting to the Associate Director, Engineering Commissioning, Qualification and Validation the successful candidate will initially be part of the Sterile Drug Product Facility (SDPF) project team working within the Lyophilizer CQV team. The candidate will be responsible for the installation and qualification of the lyophilizers used within the SDP facility.
Upon completion of the SDPF project, responsibilities will shift to a one campus approach and this role will expand scope to cover CQV activities across drug product and in the drug substance facility. The manager will lead a team of validation specialists, develop and implement validation strategies, and drive continuous improvement initiatives to enhance the efficiency and effectiveness of the sterilization and temperature mapping processes.
Key Responsibilities
Support the Sterile Drug Product Facility project as part of the CQV team responsible for the Lyophilizer qualification.
Plan, coordinate, and oversee validation activities for validation projects, ensuring timely completion and adherence to budgetary constraints.
Ensure compliance with relevant regulatory requirements, such as FDA, EMA, and GMP guidelines, as well as internal quality standards and procedures.
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 MS&T, engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives.
Develop and implement change control 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 & Experience
The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline.
Extensive experience in commissioning and qualification activities, including developing and implementing validation strategies, managing validation projects, and ensuring compliance with regulatory requirements.
Experience in conducting risk assessments and developing mitigation strategies to ensure the safe and reliable operation of systems and processes. 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. Excellent technical writing skills are essential.
Experience collaborating with cross-functional teams, including engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives.
Proven ability to identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance.
Experience supporting internal and external audits and inspections related to validation activities, including addressing findings or observations and implementing corrective actions.
Previous experience with a biologics startup facility and a good understanding of systems such as Delta V, MES, SAP is desired.
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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
#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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to 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/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585006
Updated: 2024-09-20 04:55:51.180 UTC
Location: Cruiserath-IE
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.