Engineer - Lab Systems, Cell Therapy Devens at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

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, with familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting
Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality, and lab applications
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
Excellent verbal and written communication skills
The ability to plan and lead small and medium size projects and enhancements
Self-driven

Responsibilities

Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support
Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems
Create, execute, and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure
Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders
Lead or provide supporting activities within the quality management system (Infinity)
Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training
Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration
Provide digital plant subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies
Ensure alignment with BMS directives and industry guidelines for applications
Execute on technology improvements and efficiency opportunities to improve business and compliance
Provide on-call support, as needed, for commercial operations

Skills

GxP

SDLC

IT Administration

Asset Management

Benchtop Instrumentation

Flow Cytometers

Plate Readers

Cellometers

Laboratory Systems

Quality Systems

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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