Engineer

Overview

Provide technical support to manufacturing, engineering, and other departments while working on assignments that may be complex in nature. Responsible for design and implementation of manufacturing processes using considerable judgment and initiative for resolving design and implementation issues. Apply engineering principles and standards for electrical, mechanical, electromechanical, and / or optical procedures and tests in areas such as manufacturing, development, maintenance, quality, testing, and engineering projects. Design, establish specifications, construct, inspect, adjust, test, document and maintain equipment, components, devices and systems following proper procedures and instructions.

Provide guidance, training and direction to junior or non-technical employees.  Responsible to create and edit maintenance and technical procedures as required. Supervise a team of technicians.

Responsibilities

• Strong writing and oral communication skills with in depth knowledge of Microsoft Word, Excel, and PowerPoint.
• Ability to work under pressure on multiple tasks with varied deadlines.
• Ability to work independently as well as with key internal and external constituents.
• Strong organizational skills and the ability to multi-task and integrate project segments.
• Follows Standard Operating Procedures, Protocols, Work Orders, Company Policies, and work instructions from supervisors in the course of performing his / her work functions. Performs all work in adherence to the Company’s cGMP and safety standards and procedures.
• Maintains, organizes, and keeps all engineering and other company documentation associated with Noven’s manufacturing equipment in an orderly manner. Contributes to the development and improvement of these documents.
• Accurately inspects and measures critical aspects of electromechanical components; creates and / or follows engineering drawings, and wiring diagrams. Works from and or establish specifications, drawings, manuals, sketches and verbal instructions.
• Able to accurately measure and inspect mechanical, electromechanical or electrical parts and equipment using complex metrology equipment (oscilloscope, voltmeters, indicators, comparators, microscopes, micrometers, etc).
• Maintains a clean and orderly work environment.  Practices safe work habits and completes required safety and environmental hazard training.  Able to interpret MSDS sheets.
• Examines equipment, machinery, building components and associated mechanical and electrical components to determine condition and need for work and determines need for replacement parts or repairs.
• Assist with the fabrication of new or custom-built manufacturing, research, development, and test equipment. Including software and hardware related development.
• Applies an extensive practical experience and knowledge base to develop alternative solutions to electrical / electronic or mechanical problems which may be of a difficult and / or unusual nature.
• Accurately complete the required documentation (logbooks, work orders, data entry, data sheets etc.) pertaining to installation, maintenance, spare parts holding and trouble-shooting of Noven’s manufacturing equipment. Adhere to Noven policies regarding cGMP Good Documentation Practices.
• Work closely with team and group members to achieve defined goals, and communicate effectively in recording work performed, and in offering feedback and improvement recommendations based on observations and work experience.
• Performs operational functional testing, troubleshooting and debugging of components, sub-assemblies and systems to isolate faults and suggest remedies and recommendations for changes in product or test method in a team environment
• Writes technical reports and develops charts, graphs and schematics to describe and illustrate systems / tests operating characteristics, malfunctions, deviations from design specifications, and functional limitations. Executes IQ / OQ protocols related to equipment installation and / or modification. Performs process / product tests and audits for conformity to quality and / or regulatory requirements. Records test procedures and results along with the appropriate data analysis.
• Performs such individual assignments and related duties as the supervisor may direct; establishes and maintains effective work relationship within the department, facility and company.
• Participates / leads in the design, development, execution and support of engineering projects including the drafting of technical documentation / procedures.
• Contributes to the design of tools and equipment that are critical to Noven operations.
• Conducts testing and troubleshooting of equipment and incorporates lessons learned in future improvements / projects.
• Capable of working on equipment and processes with minor supervision and takes the lead in developing improved solutions, including collaborating with vendors.
• Regularly providing design ideas and equipment improvements independently as well as in collaboration with fellow team members.
• Managing of tasks and assignments to guarantee the timely execution with a high level of certainty on their success.
• Working closely with several departments to provide continual support, resolve issues and coordinate additional testing, as needed.
• Development of cost reduction project using lean tools.
• Developing positive relationships with fellow employees to ensure equipment improvements contain the needed requirements and that changes are met with minimized interruptions to current process.
• Continually providing support and guidance to ensure transfer of equipment and process knowledge is sufficient in a continuous effort to improve equipment functionality and reduce down time.

Qualifications

Competencies :

Education / Experience :

Bachelor’s degree within an engineering discipline preferred or the equivalent technical training.  Three to six years of professional experience.  Good written and verbal communication skills in English. Knowledge of CGMPs and FDA CFR’s.  AutoCAD and PLC programming / troubleshooting a plus. Must be computer literate with knowledge of office application software (Microsoft Word, Excel, PowerPoint, ACCESS, and Outlook).

Judgment / Decision Making :

Effectively identifies problems as they occur and takes appropriate steps to solve straight-forward problems. Under general supervision, exercises some judgment in accordance with well-defined policies, procedures, techniques. Works on assignments that may be complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.  May determine methods and procedures on new assignments and may provide guidance to other non-exempt personnel

Work Environment :

Air-conditioned office environment.  Majority of time spent sitting at desk, operating computer and talking on telephone. Majority of work performed with exposure to chemicals, electrical current, fumes, moving parts, noise, and odors.

Physical Demands :

Visual and manual dexterity required to perform clerical duties, including operating office equipment and checking documents for accuracy. Occasionally required to lift and carry objects weighing up to fifty (50) pounds. Standing is often required, as well as stooping and bending. Visual acuity and manual dexterity required when performing essential duties; carelessness could result in injury.