Sr Validation Engineer at Bristol-Myers Squibb

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Expertise in commissioning, qualification, and validation (CQV) for facility, utility, analytical, and process equipment in GMP environments
Broad knowledge of engineering disciplines, particularly isolator-based aseptic processes, containment technologies, and sterile operations
Experience with process validation, cleaning validation, computer system validation (CSV), and QC asset validation
Senior-level proficiency in leading validation strategies, deviation investigations, CAPA management, change controls, and technical documentation
Ability to author, review, and approve GMP documentation including SOPs, protocols, reports, deviations, and CAPAs
Capability to guide, mentor, and cross-train team members
Experience supporting Health Authority inspections and audits
Skills in monitoring and reporting on department KPIs

Responsibilities

Serve as validation subject matter expert for commissioning and qualification of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility, including isolator-based aseptic processes
Lead the strategy and implementation of CQV programs for GMP spaces: office, warehouse, development, quality control, sterility/microbiology, and GMP production, emphasizing isolator and containment technologies
Direct and coordinate consultants and project teams in executing validation activities and continuous improvement initiatives
Partner cross-functionally with Engineering, QC, and Operations to develop and implement new processes and onboard new technologies, including advanced isolator systems
Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations
Guide, mentor, and cross-train team members to broaden validation capabilities
Own and drive key validation areas and projects, establishing and maintaining best practices for isolator technology and sterile operations
Lead complex deviation investigations, data reviews, CAPA management, change controls, and ensure robust technical documentation
Author, review, and approve GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPA, and change controls
Support and represent the validation function during Health Authority inspections and audits
Monitor and report on department KPIs to drive performance improvement
Execute and provide technical support (inferred from incomplete description)

Skills

Key technologies and capabilities for this role

ValidationCQVCommissioningQualificationGMPFacility ValidationUtility ValidationProcess EquipmentIsolator SystemsRadiopharmaceuticalsEngineering

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this position remote or onsite?

This information is not specified in the job description.

What salary can I expect for the Senior Validation Engineer role?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires expertise in commissioning, qualification, and validation (CQV) for GMP facilities, including isolator-based aseptic processes and containment technologies, along with experience leading cross-functional teams, managing investigations and CAPAs, and driving continuous improvement.

What is the company culture like at Bristol Myers Squibb and RayzeBio?

The culture emphasizes challenging, meaningful, life-changing work that transforms patients' lives, with opportunities to grow alongside high-achieving teams, balance, flexibility, and a focus on innovation in radiopharmaceuticals.

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