Engineer IT Compliance Devens Cell Therapy Facility
Engineer IT Compliance Devens Cell Therapy Facility
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. 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 highachieving 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: Summary:
The Engineer IT Compliance Cell Therapy at Devens Cell Therapy Facility (CTF) will support the development implementation and maintenance of IT/Automation (Digital Plant) processes and ensure the groups adherence to System Life Cycle standards. This role will primarily support the IT Compliance IT Deviation Management Computer System Audit Change Management Training Management and the Risk Management Programs at the Devens CTF.
Duties/Responsibilities:
Supports IT Compliance IT Deviation Management Program Computer System Audit Change Management Training Management and Risk Management Programs at the Devens CTF.
Acts as a CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects. This may include developing and executing validation plans protocols (IQ OQ PQ) and reports for computer systems and software applications used in GxP environments.
Collaborates with crossfunctional teams including IT Manufacturing Sciences and Technology Quality Assurance Manufacturing and Laboratory to ensure successful validation of systems.
Supports regulatory audits and internal audits as a Digital Plant representative responsible for inspections readiness and finding responses.
Interacts with Veeva Vault (Quality Management System) to enter deviations and associated actions investigations and associated root cause analysis supporting data corrective action/preventative action (CAPA) and effectiveness checks as needed.
Provides IT compliance support to Devens CTF Digital Plant team through owning or supporting investigations and change controls deviation ownership of computerized system events and CSV activities.
Provides support to maintaining quality system compliance against established KPIs for the Devens CTF Digital Plant team
Provides compliance support of Digital Plant programs and system maintenance activities.
Ensures that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as needed.
Reporting Relationship:
This position will report into the Devens CTF Site Sr. Manager of IT Quality and Compliance
Qualifications:
Strong knowledge of regulatory requirements and industry standards related to computer system validation (CSV) requirements (e.g. FDA EMA GAMP 5 21 CFR Part 11 Annex 11 as they apply to Cell & Gene Therapy or Biologics manufacturing.
Experience with Quality principles and QA methodologies including ISO 9001 and ICH guidelines e.g. Q7 Q9 Q10.
Experience working with global policies/procedures CGMP requirements and regulatory guidelines demonstrating the ability to work within a regulated environment for a fully automated multiproduct Cell Therapy manufacturing facility.
Experience in implementing and supporting quality systems including risk management audit readiness deviation management training management and change management programs.
Strong in project management verbal communication and technical writing skills.
Proficiency using electronic quality management systems such as Veeva Vault Quality.
Knowledge of data integrity principles and practices.
Preferred Qualifications:
Experience working with Manufacturing Systems (Syncade) Process Automation Systems DeltaV and Benchtop IT Systems.
Experience with Lean Six Sigma and Operational Excellence.
Experience developing and applying new and innovative approaches to projects and processes.
Education/Experience/Licenses/Certifications:
Engineering and science experience generally attained through studies resulting in a B.S. in Engineering Sciences or a related IT/OT discipline or its equivalent.
A minimum of 2 years of the above relevant experience preferably in the Cell Therapy or life sciences area is required.
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 Lifechanging 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.
Onsite Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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
