✦ Luna Orbit — Engineering (Non-Software)

Associate Director, Cell Therapy Network CQV

at Bristol-Myers Squibb

📍 Devens - MA - US Hybrid 💰 $175K – $212K USD / year Posted March 14, 2026
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Position Details

Salary $175K – $212K USD / year
Type Full-Time
Experience mid
Exp. Years Not specified
Education Bachelor's in Mechanical Engineering, Chemical Engineering, or related scientific/engineering discipline
Category Engineering (Non-Software)

About this role

This role involves overseeing equipment validation, commissioning, and qualification processes within a pharmaceutical manufacturing environment. The candidate will ensure compliance with GxP regulations and support validation lifecycle management.

Key Responsibilities

  • Establish validation strategies
  • Oversee equipment validation
  • Ensure regulatory compliance
  • Coordinate commissioning and qualification
  • Maintain inspection readiness

Technical Overview

The technical scope includes validation, CQV, commissioning, qualification, GxP compliance, and validation lifecycle management within GMP manufacturing settings.

Ideal Candidate

The ideal candidate is an experienced validation engineer with a background in pharmaceutical manufacturing support, CQV, and equipment qualification. They should possess strong knowledge of GxP regulations and validation lifecycle management.

Must-Have Skills

ValidationCQVCommissioningQualificationRegulatory Compliance

Nice-to-Have Skills

Lean Six SigmaProject ManagementGMP Manufacturing Support

Tools & Platforms

GxPValidation LifecycleProject Management Tools

Required Skills

ValidationCQVcommissioningqualificationGxPregulatory complianceICH guidelinesGMP manufacturingequipment validationvalidation lifecycleproject managementLean Six Sigma

Hard Skills

Mechanical EngineeringChemical EngineeringGxPValidationCQVCommissioningQualificationValidation LifecycleRegulatory ComplianceICH GuidelinesLean Six SigmaProject ManagementEquipment ValidationGMP Manufacturing

Soft Skills

Strategic ThinkingProblem-solvingDecision-makingCommunicationInterpersonal SkillsCollaborationTeam Building

Certifications

Preferred

Lean Six Sigma

Industry & Role

Industry Pharmaceuticals / Healthcare
Job Function Managing validation and CQV processes for pharmaceutical equipment and facilities.
Role Subtype Validation Engineer
Tech Domains GxP, Validation Lifecycle, Regulatory Compliance

Keywords for Your Resume

ValidationCQVCommissioningQualificationGxPRegulatory ComplianceICH GuidelinesGMP ManufacturingEquipment ValidationValidation LifecycleProject ManagementLean Six Sigmavalidationcommissioningqualificationregulatory complianceICH guidelinesGMPequipment validationvalidation lifecycleproject management

Deal Breakers

Lack of validation or CQV experience, No understanding of GxP or GMP, No experience with validation lifecycle

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