Senior Engineering Manager – Validation & CQV Leader

Pscbiotech; Nebraska; Presencial; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, and Vision

401(k) and matching

PTO, Sick Time, Holidays

Education Assistance

Pet Insurance

Fitness Perks and Discounts

Financial Perks and Discounts

Descripción de la vacante

BioTechnique is a sterile injectable full-service CDMO seeking a Senior Engineering Manager to lead Validation and Process Engineers. You will drive startup, commissioning, qualification, and ongoing validation of manufacturing systems for clinical and commercial products.

Responsibilities include CQV leadership, cross-functional collaboration, risk assessments, and ensuring compliance with FDA/EU regulations.

Formación

• Bachelor's degree or higher in engineering or life sciences.
• 10+ years in pharma/CDMO with leadership.
• Strong knowledge of sterile injectable manufacturing and validation lifecycle.

Responsabilidades

• Oversee startup and continuous operation of process equipment, utilities, and facility systems.
• Coordinate engineering and validation issues across site with multiple departments.
• Monitor process performance data and implement corrective actions.
• Develop and manage project timelines, budgets, and resources for new equipment startup.
• Establish relationships with equipment vendors and contractors.
• Lead CQV activities for equipment, utilities, processes, and systems.
• Ensure lifecycle validation activities meet cGMP and regulatory requirements.
• Review validation documentation for equipment, processes, and systems.
• Support audits, regulatory inspections, and client-facing discussions.
• Mentor Validation Engineers and Process Engineers; train new staff.

Conocimientos

Leadership

Validation lifecycle management

Regulatory compliance

Project management

Educación

Bachelor’s degree or higher in Engineering/Life Sciences

10+ years pharma/CDMO leadership experience

Descripción del empleo

BioTechnique is a sterile injectable full-service CDMO seeking a Senior Engineering Manager to lead Validation and Process Engineers. You will drive startup, commissioning, qualification, and ongoing validation of manufacturing systems for clinical and commercial products.

Responsibilities include CQV leadership, cross-functional collaboration, risk assessments, and ensuring compliance with FDA/EU regulations.