Engineer, IT Compliance, Lab and Quality Systems
Engineer, IT Compliance, Lab and Quality Systems
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$ 87000 - 102000
1 Vacancy
Job Description
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. 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: overall focus of this resource will encompass the following: laboratory and manufacturing instrument PC support and application administration local support and liaison for global laboratory and quality systems and administrator for local laboratory and quality systems. The resource will integrate information from the end user and in collaboration with matrix teams within BMS to understand opportunities for investigating and implementation of existing and emerging technology in accordance with applicable regulations and BMS approved policies and procedures.
Responsibilities:
Execute update and support staff on documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable accessible and secure.
Utilize BMS systems to support changes incidents problems and asset management activities for the support of benchtop equipment and lab and quality systems with limited guidance and provide ownership of assets.
Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
Provides digital plant subject matter expertise (SME) to multi-function teams advises operations on application configurations data integrity cyber security and defends their work before regulatory agencies.
Ensures alignment with BMS directives and industry guidelines for applications.
Execute on technology improvements and efficiencies opportunities to improve business and compliance.
Providing on-call support as needed for 24/7 commercial operations. 8. Support Quality and Manufacturing areas during audit and inspections from internal and external organizations
Work both independently and in a team environment at all levels of the organization in particular Quality Quality Control and Manufacturing Operations.
Work within all Site Facilities which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.
Knowledge and Skills:
Comprehensive knowledge of Data Integrity guidance GxP compliance Software Development Life Cycle and Good Documentation Practices.
Comprehensive knowledge of SOPs cGMPs and other compliance requirements and regulatory guidelines (FDA EU) and the know how to work and manage within a regulatory environment.
Demonstrated leadership skills and the ability to negotiate in a complex environment.
Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments quality and lab applications.
Excellent verbal and written communication skills.
The ability to plan and lead small and medium size projects and enhancements.
Self-driven and capable of prioritizing.
Expanding understanding of network databases servers and PCs.
Understanding of usage and administration of Waters NuGenesis.
Familiarity with Empower and one or more LIMS LES/ELN and Document Management Systems. Management System and emerging technology is preferred.
Developed system and business analysis skills
Ability to apply lean and OpEx principles.
Project management communication and technical writing skills are required.
The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders regulatory agencies and management.
Ability to sense understand and react to others emotions and recognize the impact of their emotions on your and others performance and behaviors.
Qualifications:
BS degree in life sciences engineering or computer field or equivalent experience.
Minimum of 2 years of experience working in regulated industries such as Biotech Pharmaceutical and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
The starting compensation for this jobis a range from $87000 - $102000 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed.
Final individual compensation will be decidedbased on demonstratedexperience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit 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 -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 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.
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 a supportive culture promoting global participation 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 an 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 . Visit 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Employment Type
Full-Time
