Corporate Engineer (Oral Solid Dose)

Job Description

Plan, coordinate, and direct technical activities to improve processes and systems that support manufacturing.

REQUIREMENTS EDUCATION

Required: Bachelors Degree
Preferred: Baccalaureate Degree in Engineering

EXPERIENCE

Required: 3 years technical experience
Preferred: 5 years engineering experience, preferably in solid-dose pharmaceutical manufacturing

SKILLS/KNOWLEDGE AND/OR ABILITIES

• Ability to apply safety principle and practices related to the use of all types of tools and equipment
• Research, recommend and supervise installation of improved manufacturing facilities and equipment
• Knowledge of cGMP guidelines and FDA regulations
• Ability to correctly identify a wide variety of mechanical, electrical and system problems
• Ability to maintain cooperative working relationship with other personnel and be an effective communicator
• Ability to direct the work of assigned personnel and travel to different sites
• Ability to be available for emergency call or on call duty
• Ability to exercise good judgment, flexibility, creativity and sensitivity in response to changing manufacturing needs
• Ability to perform duties in an independent manner while complying with Corporate Operating Procedures (COP)
• Must be able to install, operate, maintain and repair a variety of types of equipment safely in accordance with operating instructions, GMPs and other applicable regulations
• Extensive knowledge of current computerized engineering and drafting is required
• Has the authority to take action to meet the responsibilities and perform the duties described herein within the limitations established in the Corporate Operating Procedures, current Good Manufacturing Practice Act, Standard Operating Procedures and other applicable policies or as established by supervisors from time to time

GENERAL RESPONSIBILITIES

• Responsible for planning, directing and coordinating activities concerned with design, construction, modification and maintenance of equipment and machinery
• Responsible for establishing standards and policies for installation, modification, quality control, testing, operating procedure, inspection, and maintenance of equipment according to engineering principles and safety regulations
• Responsible for coordinating requirements for new designs, surveys and maintenance schedules for equipment and machinery
• Responsible for preparing bid sheets and contracts for construction and facilities acquisition and testing newly installed machines and equipment to ensure fulfillment of contract specifications

SPECIFIC DUTIES AND TASKS

• Analyze manufacturing requirements, procedures and problems to improve existing processing and systems
• Conduct studies pertaining to the development of new methods to meet current and projected manufacturing needs
• Prepare time and cost estimates for completing projects
• Establish standards and policies for development and implementation of technical projects
• Develop procedures for installation, testing, operation, inspection and maintenance of processes and equipment
• Test newly installed machines and equipment to ensure fulfillment of contract specifications
• Understand physical characteristics of electro-mechanical equipment and buildings
• Plan time and motion studies
• Work on special projects as assigned
• Develop specifications for equipment and systems
• Originate protocols for validations
• Find and evaluate outside vendors and contractors for equipment, materials and projects
• Evaluate bids and proposals from vendors and contractors.