Lead Engineer, CSV at Bristol-Myers Squibb

Summit, New Jersey, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

BS degree or equivalent experience
Minimum 5 years of experience

Responsibilities

Supports equipment qualification and validation activities
Investigate and resolve Deviations, CAPA investigations and other potential issues
Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions
Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls
Initiates, manages, and leads projects of moderate scope and complexity within their functional area
Manages projects of varying scope and complexity
Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment
Author quality procedures and training documents
Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
Support growing standardization efforts in the review and approval of Validation Deliverables
Promotes and provides excellent customer service and support
Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests
Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues
Interfaces with customers to ensure all expectations are being met
Ensure equipment, facilities and programs are maintained in compliance

Skills

CSV

Computer System Validation

Equipment Qualification

Validation Activities

Deviation Investigation

CAPA

GAMP

GMP

Manufacturing Equipment

Laboratory Equipment

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.

Land your dream remote job 3x faster with AI

Try Jobo Free