#Oralsoliddosage
hashtag#pharmaceuticalosdmanufacturing
hashtag#Chantillyusajob
hashtag#opentnvisa
hashtag#hvacsystems
Hi All repost below !
Senior Manager, Engineering (Oral Solid Dosage)
Chantilly, Virginia, USA
Domain
Pharmaceuticals/Biotechnology/Clinical Research
Experience
10 - 25 Years
Location
USA - Chantilly
Open to give TN Visa
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.
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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