This job has expired

You will need to login before you can apply for a job.

Manager, Validation Engineer

Employer
Bristol Myers Squibb Company
Location
Seattle, Washington
Start date
Dec 6, 2023

View more

Discipline
Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

Position Summary

The Manager, Validation Engineer is a skilled engineer who is responsible for validation support to the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bristol Myers Squibb Manufacturing Plant (Jump), Bothell, WA. This individual contributor role will be responsible to oversee the Reliability Engineering and New Technology Introduction focus areas and for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during validation activities. This includes developing and delivering GMP equipment, facilities, and utilities validation programs to ensure compliance with applicable cGMPs and global health authority regulations. The Manager, Validation Engineer will partner with cross-functional teams to develop validation plans and ensure their execution and lifecycle management. The Manager, Validation Engineer I oversee ad hoc teams performing engineering activities, ensures the completion of all deliverables and develops the long-term strategy of the focus areas.

Duties/Responsibilities

  • Develops and executes validation plan for cGMP critical equipment and system with validation document deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and data integrity requirements.
  • Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
  • Executes and/or leads multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.
  • With minimal supervision, leads one or more projects within the Reliability Engineering and New Technology Introduction areas and contributes to more complex projects and initiatives for the broader site. Occasionally leads complex technical project teams and cross-functional teams.
  • Lead/assist new facility and utilities design, incorporation of new technology/processes/equipment, and/or upgrade current assets.
  • Responsible for Engineering activities including: Design of Manufacturing facility workstations and room layout, implementation of Manufacturing processing equipment and systems, design of utilities intended to support the manufacturing process equipment and systems, and Support the start-up or reconfiguration of new manufacturing production areas within the facility
  • Work collaboratively with peers within the cross-functional teams (F&E, IT, MFG, QC, Supply Chain, and QA/QEV) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
  • With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
  • Leads teams with specialized focus on strategic validation projects to evolve the organization. With some frequency, makes an impact on the broader validation team.
  • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
  • Maintains and continually improves the commissioning and qualification program aligned with current international standards and regulatory agencies.
  • Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
  • Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works to address perceived deficiencies.
  • Support GMSAT including our R&D site to execute validation related projects and make standardization across the sites.

Qualifications

  • Bachelors Degree in life sciences/engineering/STEM or equivalent
  • 5+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries
  • Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements
  • Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation practices are required.
  • Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry are required.
  • Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents through system retirement.
  • Excellent project and program management, communication skills, and technical writing skills are required.
  • Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired.
  • Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
  • Experience in the Pharma/Biopharma required, cell therapy industry is plus.
  • Detail oriented, with strong GMP, Validation and Engineering experience
  • Experience utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions.

The starting compensation for this job is a range from $92,000 - $115,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.

For more on benefits, please visit our BMS Careers site.

Eligibility for specific benefits listed in our careers site may vary based on the job and location.

Benefitofferingsare subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical, pharmacy, dental and vision care. Wellbeing supportsuch asthe BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Years holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART VETERAN

If you come across a role that intrigues you but doesnt 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 adastaffingsupport@bms.com. Visit careers.bms.com/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 is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

Facebook Instagram Twitter YouTube Logo

Company info
Website
Telephone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert