Senior Validation & Process Engineering Lead

PSC Biotech; York (York County); Presencial; USD 150.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

401(k) and matching

Paid Holidays

Education Assistance

Pet Insurance

Fitness Perks

Discounts

Descripción de la vacante

BioTechnique is seeking a Senior Engineering Manager to lead Validation and Process Engineers at our CDMO site. You will steer startup, commissioning, qualification, validation, and ongoing operation of sterile manufacturing systems to support clinical and commercial products.

You will oversee CQV activities, manage timelines and budgets, and maintain compliance with FDA/EU regulations while collaborating across QA, Manufacturing, Facilities, MSAT, and Supply Chain.

Formación

• 10+ years of pharmaceutical/CDMO experience with leadership responsibility
• Strong understanding of sterile injectable manufacturing and validation lifecycle
• Experience supporting FDA inspections, capital projects, equipment startup, and client-facing operations
• Knowledge of 21 CFR Part 11/210/211 and cGMP regulatory guidelines

Responsabilidades

• Oversee startup and continuous operation of process equipment, utilities, and facility systems for sterile manufacturing
• Lead CQV activities for equipment, utilities, processes, and systems
• Manage validation documentation and ensure compliance with AQance ACE/Kneat systems
• Collaborate with Quality Assurance, Manufacturing, Facilities, MSAT, and Supply Chain on tech transfers and process changes
• Support audits, regulatory inspections, and CAPA/investigations

Conocimientos

Leadership

Project management

CQV

Validation lifecycle

Regulatory compliance

Cross-functional collaboration

Problem solving

Educación

Bachelor’s degree or higher in Engineering / Life Sciences

Herramientas

ACE®

Kneat Paperless Validation System

Descripción del empleo

BioTechnique is seeking a Senior Engineering Manager to lead Validation and Process Engineers at our CDMO site. You will steer startup, commissioning, qualification, validation, and ongoing operation of sterile manufacturing systems to support clinical and commercial products.

You will oversee CQV activities, manage timelines and budgets, and maintain compliance with FDA/EU regulations while collaborating across QA, Manufacturing, Facilities, MSAT, and Supply Chain.