Senior Manager Validation Engineering at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

B.S. degree in a scientific, technical, or engineering discipline
Minimum of 6 years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in a biologics manufacturing environment
Knowledge of Engineering and Quality Assurance generally attained through studies or applicable industry experience

Responsibilities

Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility, and processing equipment systems
Lead functions responsible for installation, operational, and performance qualification (I/O/PQ) of systems arising from projects and change controls
Lead the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance, and ensure execution to predefined schedule
Establish validation project plans commensurate with the level of risk and manage execution of validation projects requiring coordination with customers, collaborators, and quality
Provide oversight of validation execution work from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs, in conjunction with Validation Management peers, Validation Program management, and Quality Assurance
Deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, including establishment of plans, protocols, test scripts, risk assessments, and summary reports
Manage multiple projects while serving as a point of contact for validation execution projects
Act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Board Of Health (BOH) inspectors and auditors
Work collaboratively with Engineering, Digital Plant, Manufacturing, and Quality
Effectively manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Ensure alignment with BMS directives and industry guidelines on validation
Develop and lead a high-performance team responsible for validation execution, manage recruitment and development of staff, invest in leadership development through coaching, mentoring, and rewards/recognition
Establish and communicate high performance standards, define clear accountability, and lead by adopting continuous improvement strategies to reduce operational variances and cycle time

Skills

Validation Engineering

IQ/OQ/PQ

Requalification

Project Management

Change Control

Risk Assessment

Regulatory Compliance

Facility Qualification

Utility Qualification

Equipment Qualification

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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