Director of Engineering & Reliability
Job Description
Onsite leadership role responsible for Reliability Services and Engineering support from early research through clinical production. Provides hands-on technical guidance, oversees engineering teams, and ensures reliable operation of equipment, utilities, and facility systems.
Key Responsibilities
- Lead site engineering, equipment procurement, and facility support.
- Oversee commissioning, qualification, and validation activities.
- Manage teams responsible for reliability, project services, and equipment ownership.
- Drive system improvements, operational excellence initiatives, and SOP development.
- Contribute to site planning, design concepts, and engineering standards.
- Maintain compliance with industry and regulatory requirements.
- Manage department budget.
Skills & Experience
- Strong mechanical, electrical, instrumentation, and computer systems expertise.
- Deep knowledge of CGMP, OSHA, EPA, and FDA requirements.
- Hands-on troubleshooting ability across facility systems and equipment.
- Excellent leadership, communication, and documentation skills.
- Ability to specify, validate, and maintain facility and process equipment.
Qualifications
- BS in Chemical, Electrical, or Mechanical Engineering.
- 15+ years in pharmaceutical operations or maintenance, ideally including oral solid dose and lab environments.
- Experience in automation, validation, utilities, and facility design.
FAQs
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