Senior Engineering Leader, OSD Manufacturing & Compliance

Energy Jobline ZR; Chantilly (VA); In loco; USD 180.000 - 230.000; Tempo pieno

Descrizione del lavoro

Energy Jobline ZR is seeking a Senior Manager, Engineering (OSD) in Chantilly, VA to lead reliability, compliance, and modernization at a GMP pharmaceutical site.

You will drive capital projects, oversee HVAC and clean utilities, and ensure FDA/cGMP adherence while mentoring cross-functional teams.

This role requires hands-on leadership in a regulated environment with a track record in Lean and Six Sigma initiatives.

Competenze

• Deep expertise in Oral Solid Dosage manufacturing and equipment.
• Strong knowledge of HVAC, clean utilities, and environmental controls in pharma.
• Experience with validation, change control, and regulatory audits.
• Hands-on leadership in facility engineering within a GMP environment.
• Skilled in risk assessments such as FMEA or HAZOP.

Mansioni

• Lead engineering and facility operations across OSD manufacturing and packaging.
• Oversee maintenance, reliability, and performance of critical equipment.
• Manage HVAC, clean utilities, and facility systems to meet cGMP standards.
• Drive capital projects, upgrades, and infrastructure improvements.
• Ensure compliance with FDA, cGMP, and safety regulations.
• Lead root cause investigations and implement CAPA solutions.
• Champion continuous improvement using Lean and Six Sigma.

Conoscenze

Oral Solid Dosage

HVAC & clean utilities

Regulatory audits

Validation & change control

GMP leadership

FMEA / HAZOP

Descrizione del lavoro

Energy Jobline ZR is seeking a Senior Manager, Engineering (OSD) in Chantilly, VA to lead reliability, compliance, and modernization at a GMP pharmaceutical site.

You will drive capital projects, oversee HVAC and clean utilities, and ensure FDA/cGMP adherence while mentoring cross-functional teams.

This role requires hands-on leadership in a regulated environment with a track record in Lean and Six Sigma initiatives.