Senior Validation Engineer, Scientist (Sterilization), Sterile Drug Product Manufacturing, Science & Technology

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 isseekingto recruit a permanentSenior Validation Engineer/Scientist (Sterilization), Sterile Drug Product Manufacturing, Science & Technology.Reporting to the Associate Director process engineering, Sterile Drug Product Manufacturing, Science & Technology, this role will be the Validation Lead for all validation aspects of all process equipment being installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. The successful candidate will be part of a multi-functional team charged with the delivery of the significant capital investment and will be accountable for all sterilization and cleaning validation aspects of the process equipment. Upon completion of the project, you will continue to support the sustaining operation on site as well as acting as a global Subject Matter Expert (SME) within the organization.

Key Responsibilities
Develop a strategy to ensure that the validation approachfor the newSDP facilitysatisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective andappropriate useof processdevelopment.

Development andexecution ofallocatedvalidations according to theSDPValidation Master Plan.

Produce andmaintainappropriateand comprehensive validation policiesand procedures.

Act as leadforall technical and equipment validationactivitiesfromdesign to successful PPQ of products within theSDPfacility, and after which will support routine production of thefacility.

Manage the activities of a defined team of Validation Engineers. Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications, and general personnelassistanceduring their duties

Ensure that the design, installation and operation of Plant and Equipment have beenvalidatedin compliance with current regulatoryrequirements.

Provide input,monitor,and report compliance on the content of the Validation Master Plan in conjunction with theappropriate Primaryteams, and corresponding Management Reviews.

Ensure thereview and approval of validation lifecycle documentation and ensure they are writtenin accordance withthe company standards andprocedures.

Develop andmaintainprocesses and procedures to ensure producttechtransfers are achievedefficiently.

Draft andapprove testprotocoland reports asrequiredalong with supporting the execution of IQ/OQ and PQactivities for SDPduringstart upasrequired.

Publish site specific progress reports asrequired.

Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]

Validation SMEin regulatory audits and inspections.

Support site change control procedures

Any other reasonable duties which may be required bymanagement.

Qualifications & Experience
Deep technical knowledge of Sterile Drug Product manufacturing equipmentvalidationand sterilisation.Specifically in the areas of sterile fillingand associated equipment.

Knowledgeable on current industry practices and regulatory requirements withintheSterile Drug Product manufacturingarea.

Familiar with start-up of new Sterile Drug Product manufacturing facility frominitialdesign through to the final qualification of the equipment.

First-hand experience of qualification and validation ofSterile Drug Productmanufacturing equipment and/or processes.Specificallyin the area ofSterile Filling and Isolator equipment.

The successful candidate mustpossessa Bachelor/master's in engineering, orSciencerelated discipline. A minimum of5years' experience withina SterileDrug Product Manufacturingis essential.

Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercialmanufacture.

Experience withQualification and Validationof newequipmentis essential, as well as experience interacting with regulatory agencies.

Experience withTechnical Transferof newprocessesisdesirable.

The candidate will havedemonstratedproficiencycommunicating and collaborating at a variety of levels, coupled with excellent organization and planning skills.

Problem solving and project management ability, as well as lean manufacturing experience is essential.

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.

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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.

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