Senior Engineer, IT Computer System Validation (CSV) at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

B.S. in science, engineering, biochemistry or related discipline, or equivalent
Minimum of six (6) years of relevant experience in a regulated environment
At least four (4) years focused on quality assurance, validation, or compliance

Responsibilities

Gain a thorough understanding of computer systems deployed at Devens CTF
Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects – advising operations on CSV matters and defending work before regulatory agencies
Provide day-to-day oversight of the CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate
Drive and own the validation lifecycle documentation for newly implemented computerized systems
Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects
Review and approve validation lifecycle documents as part of CSV activities, supporting risk assessments, specifications, pre- and post-approval of qualification testing
Participate in regulatory audits as Digital Plant secondary representative and assist in generating responses to audit observations
Provide IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities
Interact with Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed
Interact with ServiceNow to review and approve digital changes
Provide quality support of Digital Plant programs and system maintenance activities
Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation associated to computerized systems
Ability to support on-call deviations on a rotational basis
Perform project audits as the needs arise
Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as it pertains to CSV responsibilities as needed

Skills

CSV

Computerized System Validation

IT Automation

Deviation Management

Change Control

Qualification Testing

Regulatory Compliance

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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