Associate, Equipment Commissioning & Qualification (ECQ) Delivery at Bristol-Myers Squibb

Summit, New Jersey, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
Basic understanding of pharmaceutical, manufacturing and laboratory systems
Strong written and verbal communication skills
Excellent interpersonal skills

Responsibilities

Maintain qualified equipment systems in compliance with policies, guidelines and procedures
Assist in the development of qualification protocols, and associated reports while adhering to a change management process
Participate in execution of equipment qualifications and validation protocols
Collaborate with vendors for qualification functions
Contribute to equipment qualification/validation activities
Aid in the creation of commissioning/qualification deliverables such as, Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports
Support Change Management process
Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area
Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates
Complete all qualification and validation documentation with accuracy, completeness and compliance with BMS standards
Regularly review, prioritize and promptly respond to customer equipment qualification and support requests
Provide troubleshooting assistance on equipment, facilities and utilities commissioning/qualification issues
Interface with customers to ensure expectations are being met
Maintain a positive relationship with all team members and site customers while promoting a positive team environment
Ensure equipment, facilities and programs are maintained in compliance
May participate in deviation investigations as SME

Skills

Equipment Commissioning

Equipment Qualification

Validation

GMP

Utilities Qualification

Facility Qualification

Lab Instruments

Analytical Skills

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