Home
/
Comprehensive
/
Principal Engineer (Sterile Filling), Sterile Drug Product Manufacturing, Science & Technology
Principal Engineer (Sterile Filling), Sterile Drug Product Manufacturing, Science & Technology-September 2024
Cruiserath
Sep 21, 2024
ABOUT BRISTOL MYERS SQUIBB
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Principal Engineer (Sterile Filling), 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 is seeking to recruit a permanent Principal Engineer (Sterile Filling), Sterile Drug Product Manufacturing, Science & Technology. Reporting to the Associate Director, Sterile Drug Product Manufacturing, Science & Technology this role will be the Technical Lead for the Vial/Syringe Filling lines being installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. You will be part of a multi-functional team charged with the delivery of the significant capital investment and will be the accountable for all technical aspects of this process and 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 organisation.

  Key Responsibilities

  Technical leadership for a new Vial / Syringe Filling line from Design to successful PPQ of products within the facility, and after which will support routine production of the facility.

  Ensure that start-up project scope and timelines meet the user requirements and work with the project & CQV team to facilitate delivery, validation and safe operation of the Vial / Syringe Filling lines and other supporting equipment / processes.

  Will be acting Fill Line SME in support of internal and external audits.

  Will have an in-depth knowledge of process operations and process equipment to support Manufacturing, Quality, Automation, Validation, and EHS for quality deviation investigation, change controls, and CAPA’s.

  Technical expert for the Fill Line equipment and accountable for changes to ensure continued compliance of the manufacturing equipment. Develop and manage projects arising from changes and to improve equipment up times. Generation of scope and budget requirement for any Equipment/Automation improvements/modifications/projects.

  Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.

  Support Technical Transfers and New Product Introduction. Part of a cross-functional project team, providing key Process/Equipment SME input during design stage and providing engineering support as required, during execution of NPI campaigns.

  Qualifications & Experience

  Deep technical knowledge of Sterile Drug Product manufacturing both from a process and equipment perspective. Specifically in the areas of sterile filling and associated equipment.

  Experience on the implementation of new primary packaging components and single use systems within Sterile Drug Product facilities.

  Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area.

  Familiar with start-up of new Sterile Drug Product manufacturing facility from initial design through to the final qualification of the equipment and process including media fills.

  First-hand experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes. Specifically in the area of Sterile Filling and Isolator equipment.

  The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline. A minimum of 10 years’ experience within a Sterile Drug Product Manufacturing is essential.

  Deep and demonstrated understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for vial and syringe filling employing isolator technology

  Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture

  Experience with Qualification and Validation of new equipment is essential, as well as experience interacting with regulatory agencies.

  Experience with Technical Transfer of new processes is desirable.

  Previous experience with a biologics startup in a large-scale drug substance facility and a good understanding of systems such as Delta V, MES,SAP is desired.

  The candidate will have demonstrated proficiency communicating 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, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

  #LI-Onsite

  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

  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  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 [email protected] . 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.

  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: R1573073

  Updated: 2024-01-22 12:03:55.065 UTC

  Location: Cruiserath,Ireland

  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.

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
Health Technician (Dietetic)
Summary The Dayton Veterans Affairs Medical Center (VAMC) is recruiting for a Health Technician. The Health Technician will function with in Nutrition and Food Services. The primary purpose of the po
Dispatcher
Dispatcher Location19 Natalie Way Plymouth, Massachusetts 02360 USPhone NumberCategoriesOperation SupportReq IDJR1372 Dispatcher (Open) First for a reasonFirst Student is the largest school transport
Water / Wastewater Engineering Manager 6 - US Hybrid
Water / Wastewater Engineering Manager 6 - US Hybrid Date: Jan 23, 2024 Location: US Company: Black & Veatch Family of Companies Together, we own our company, our future, and our shared success.
Pharmacy Technician
Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced
Hotel Laundry Attendant
Req ID: 431582 Address: 7101 W. Sundust Rd Chandler, AZ, 85226 Welcome to Love’s! * * Where People are the Heart of Our Success * * Hotel Laundry Attendant Laundry Attendants are expected to maintain
Senior Member of Technical Staff (JoinOCI-SDE)
Job Description We are seeking a strong engineer to join our team which is focused on building and maintaining a scalable software control platform for Compute Infrastructure. Major focus areas of so
Phlebotomist
Description Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We’re growing fast. [You can, too!] There are so
Creative Lead / Designer II
Company Summary DISH, an EchoStar Company, is a Fortune 250 that is reimagining the future of connectivity. For over 40 years, we’ve been challenging the status quo and evolving our company to antici
Intermediate Compliance Specialist (Hybrid Work Option)
36718BR Requisition ID: 36718BR Business Unit: COR Job Description: CDM Smith is seeking an Intermediate Compliance Specialist to join our Corporate Compliance Team. This individual performs basic to
L2 Customer Technical Support Analyst - MICROS - Simphony/Ebusiness
Job Description L2 Customer Technical Support Analyst - MICROS - Simphony/Ebusiness Location: Orlando, FL or Columbia, MD highly preferred No visa sponsorship is available for this position. As a mem
Copyright 2023-2024 - www.zdrecruit.com All Rights Reserved