88503 Senior Manager, Engineering (Oral Solid Dosage)

Cephas Consultancy Services Private Limited

Chantilly (VA)

On-site

USD 150,000 - 210,000

Full time

13 days ago
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Job summary

Cephas Consultancy Services Private Limited in Chantilly, VA seeks a Senior Manager of Engineering for the Oral Solid Dosage site. You will lead engineering and facility operations, ensure regulatory compliance, and drive reliability across HVAC, clean utilities, and packaging lines.

The role requires 12+ years in pharmaceutical OSD engineering, cGMP knowledge, and a proven leadership track record. Responsibilities include CAPA, audits support, and continuous improvement initiatives in a

Qualifications

  • Bachelor's degree in mechanical, chemical, electrical engineering, or related field.
  • 12+ years of engineering experience in pharmaceutical OSD manufacturing.
  • Strong knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.
  • Proven leadership experience managing engineering and facility teams.
  • Deep understanding of cGMP, validation, and regulatory requirements.

Responsibilities

  • Lead and manage engineering teams supporting OSD manufacturing, packaging, utilities, and facility systems.
  • Oversee installation, qualification, and maintenance of OSD equipment such as granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines.
  • Oversee operation and maintenance of HVAC systems, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and other critical utilities.
  • Ensure all engineering and facility operations comply with cGMP, FDA, EU, and internal quality standards.
  • Champion a strong safety culture across engineering and operations.
  • Mentor and develop engineering and facility staff, fostering technical growth and leadership capability.

Skills

Leadership
Engineering leadership
OSD manufacturing
cGMP knowledge
Regulatory compliance
Root cause analysis

Education

Bachelor’s degree in mechanical, chemical, or electrical engineering, or related field

Job description

88503 Senior Manager, Engineering (Oral Solid Dosage)

Cephas Consultancy Services Private Limited Chantilly, Virginia, United States

About this position

Positions:1 Full Time
Experience
10 - 25 Years

Position Overview

We are seeking an experienced and highly motivated Senior Manager of Engineering to lead all engineering and facility operations within our Oral Solid Dosage (OSD) manufacturing site. This role oversees equipment reliability, facility systems, utilities, capital projects, and continuous improvement initiatives while ensuring full compliance with cGMP, safety, and regulatory standards. The ideal candidate brings deep technical expertise in OSD processes and strong knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.

Key Responsibilities
Engineering Leadership

Lead and manage engineering teams supporting OSD manufacturing, packaging, utilities, and facility systems.

Provide technical direction for troubleshooting, equipment optimization, and process improvements.

Develop longterm engineering strategies that support operational excellence and asset reliability.

OSD Equipment & Process Support

Oversee installation, qualification, and maintenance of OSD equipment such as granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines.

Ensure equipment operates at peak performance with minimal downtime.

Lead rootcause investigations and implement CAPA for equipment and process issues.

Experience in PM and Calibration of the equipment.

Facility Engineering & Utilities Management

Oversee operation and maintenance of HVAC systems, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and other critical utilities.

Ensure environmental controls meet cGMP requirements for temperature, humidity, pressure differentials, and air quality.

Manage facility maintenance programs, preventive maintenance schedules, and reliability initiatives.

Support facility expansions, renovations, and infrastructure upgrades.

Ensure compliance with OSHA, environmental regulations, and internal safety standards.

Compliance & Quality

Ensure all engineering and facility operations comply with cGMP, FDA, EU, and internal quality standards.

Support audits, inspections, and documentation requirements.

Maintain engineering documentation, change controls, and validation protocols.

Safety & Risk Management

Champion a strong safety culture across engineering and operations.

Conduct risk assessments (FMEA, HAZOP) and implement engineering controls to ensure safe operations.

Ensure facility systems meet safety, environmental, and regulatory requirements.

Drive initiatives to improve equipment reliability, reduce downtime, and enhance process efficiency.

Implement Lean, Six Sigma, and reliability engineering methodologies.

Identify opportunities for automation, modernization, and energy efficiency.

Team Development

Mentor and develop engineering and facility staff, fostering technical growth and leadership capability.

Build a collaborative, highperformance engineering organization.

Qualification Required

Bachelor’s degree in mechanical, Chemical, Electrical Engineering, or related field.

12+ years of engineering experience in pharmaceutical OSD manufacturing.

Strong knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.

Proven leadership experience managing engineering and facility teams.

Deep understanding of cGMP, validation, and regulatory requirements.

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