|Job Title||Asst. Vice President, Engineering|
|Location||College Station, TX 77845|
|Description||Title: Sr. Director, Engineering
Department: Facility Engineering
Location: College Station, TX, USA
Employment Type: Full Time
Summary: The Sr. Director, Engineering will manage, support and provide direction and leadership for all engineering functions (e.g. the Facility Engineering, Metrology, Calibration and Validation Environmental Health & Safety, and security).
· Provide management and technical consultation to employees, contractors, and consultants across all facilities in the support of engineering, utilities, maintenance, CAPEX, and facilities related projects, contracts and ongoing operations.
· Plan annual engineering/facilities budget and develop/negotiate contracts with service providers.
· Manage multiple concurrent capital projects.
· Oversee the planning and implementation of facilities and equipment qualification and validation plans.
· Responsible for all aspects of planning and executing projects, while taking GMP Regulatory Compliance and EH&S expectations into consideration.
· Develop capital improvement plans.
· Oversees the development and implantation of all facility improvement and preventive maintenance plans.
· Oversees the development and implementation of facility security plans and processes.
· Oversees the development and implementation of Metrology processes and practices to ensure essential functions (e.g. calibration, first article inspection, specialized measuring equipment programming, etc.) are executed to meet business and regulatory requirements.
· Direct cross-functional teams to meet manufacturing needs.
· Manage scope to maintain schedule and budget requirements.
· Resolve technical problems during design phase to limit construction change orders.
· Subject Matter Expert in site utilities, which includes but not limited to: HVAC, Purified Water, Electrical Systems (Utility, Generator and UPS), Compressed Air, Nitrogen, Chilled Water, Heating Hot Water, Steam/Condensate and Sewer. Develop and update SOPs related to new and existing systems.
· Experience in maintaining regulatory compliance thru audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support.
· Works independently and within teams to uncover and resolve issues associated with the ongoing operations.
· Demonstrates flexibility in organizing work and priorities.
· Building Management System (BMS) and Environmental Management System (EMS) experience.
· Participates in development and commercialization of new technologies.
· Other duties as assigned.
Required Skills & Abilities:
· Knowledge of engineering principles, practices, theories and technologies related to equipment controls, mechanical or electrical/electronic systems and processes
· Knowledge and understanding of the techniques and procedures of engineering project management as well as OSHA regulations and safe work practices
· Skill in use of word processing software, spreadsheet software, and other systems as required
· Must have experience working in the following areas:
o HVAC Systems supplying controlled condition air to clean room and non-clean room environments
o Process Chilled Water system
o Water Systems (RODI, Purified, or Water For Injection Systems)
o Building Automation/Monitoring and Control Systems
o Building Security/Access Systems
o Instrument/Process Air Systems
o Waste Inactivation and Neutralization Systems
o Drafting and implementing Standard Operating Procedures for maintenance, pest control, and metrology.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
· Experience prolonged sitting, standing, walking, bending, stooping and stretching.
· Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
· Have a normal range of vision.
· Climb ladders and stairs of various heights.
· Be exposed to wet or humid conditions.
· Be exposed to outdoor weather conditions.
· Be exposed to noisy environments.
· Requires a Bachelor of Science in Engineering
· At least 15 years of engineering experience including 10 years of management experience.
· Experience in a cGMP clinical manufacturing facility strongly preferred.
· M.S. in Engineering is preferred.
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