Senior Specialist, Equipment Commissioning & Qualification at Bristol-Myers Squibb

Warren, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Technical expertise in commissioning, qualification, and validation (CQV) for process equipment
Ability to author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables
Proficiency in authoring, reviewing, and approving equipment risk assessments, system categorization assessments, and change control impact assessments
Experience proposing, presenting, and executing change controls for equipment introduction, modification, and retirement
Capability to provide input and feedback on change strategy, qualification approach, compliance gaps, and risk mitigation
Skills in reviewing and approving calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests in computerized maintenance management systems
Experience procuring new CQV equipment and implementing associated procedures
Ability to train new users on CQV equipment operation and troubleshooting
Proficiency in creating, revising, and reviewing procedural documents for CQV equipment (e.g., temperature/humidity mapping systems, CO2 instruments, LN2 foggers)
Skills in coordinating system usage to maintain CQV timelines while adhering to calibration and maintenance schedules
Experience performing data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment
Ability to lead and support workflows for quality events including deviations, investigations, proactive initiatives, and corrective/preventive actions
Capability to create, revise, and periodically review procedural documents related to compliance

Responsibilities

Support the Commissioning, Qualification, and Validation (CQV) team as an individual contributor on CQV deliverables, including authoring, reviewing, approving, and executing protocols, plans, reports, deviations, risk assessments, system categorizations, and change control impacts
Propose, present, and execute change controls for equipment introduction, modification, and retirement, providing input on strategy, qualification, compliance, and risk mitigation
Review and approve calibration plans, preventative maintenance schedules, system criticality assessments, alarm assessments, and asset change requests in the computerized maintenance management system
Procure new CQV equipment and implement procedures to support process equipment qualifications; train users and troubleshoot as needed
Create, revise, and periodically review procedural documents for CQV equipment such as temperature/humidity mapping systems, CO2 instruments, and LN2 foggers
Coordinate system usage to maintain CQV timelines while adhering to calibration and maintenance schedules
Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment
Lead and support quality event workflows, including deviations, investigations, proactive initiatives, and corrective/preventive actions
Create, revise, and periodically review compliance-related procedural documents

Skills

Equipment Commissioning

Equipment Qualification

Process Equipment

Facilities Operations

Laboratory Support

Project Management

Technical Expertise

GMP Compliance

Validation

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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